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Cure Research Media Monitor

Scientific research into curing HIV infection has expanded significantly in recent years, gaining a much higher profile in the press. Unfortunately, media coverage of cure research can be inaccurate and tends to overhype preliminary results. The purpose of this page is to provide TAG’s perspective on cure research in the news, with the aim of placing stories in context and addressing any inaccuracies. A glossary of terms used in HIV cure research is available on the DARE Collaboratory website. Links to recent cure research coverage by both the mainstream media and community sources can be found on TAG's cure research resource page.

November 2019 

Story:  American Gene Technologies HIV Gene Therapy

Examples of media coverage: 

  1. Gene Tech Company Claims to Have Found a Cure for HIV/AIDS – NewNowNext, November 8, 2019
  2. Researchers believe they’ve found the cure for HIV/AIDS – Pink News, November 8, 2019
  3. Research Lab Believes They Have HIV/AIDS Cure – Instinct Magazine, November 7, 2019
  4. American Gene Technologies believes they have the cure for HIV/AIDS –, November 6, 2019
  5. Here’s Why the First Cure for HIV Could Emerge from Maryland – BioBuzz, November 6, 2019

Original source:

  1. American Gene Technologies Hosts Celebration Event For Its First IND Submission (For HIV) To The Food and Drug Administration (FDA) - American Gene Technologies Press Release, November 6, 2019

TAG's commentary: This sudden burst of misleading media coverage appears to trace back to two relatively low-profile local news stories from Maryland, USA, where the Biotech company American Gene Technologies is located. 

The hyped-up headline of one of these stories (published by was appropriated for a piece in Instinct Magazine that contains no context or analysis, and that led to a deluge of similarly shallow reporting. 

The original local news stories were prompted by an event hosted by American Gene Technologies to celebrate submitting an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA). The application seeks regulatory permission to conduct a phase I first-in-human clinical trial of an experimental gene therapy for HIV named AGT103-T. The submission was first announced last month. 

The application is an important milestone for the company, but it does not mean that their gene therapy is a cure for HIV infection. There are as yet no results from either laboratory experiments or animal studies to support claims that it could have a curative effect. 

Some of the news stories cite the 1,000+ page length of the IND application as if it’s evidence of the potential of the approach, but this is normal. For any new experimental candidate, the FDA requires the submission of extensive evidence about composition, safety and other issues in order to allow administration to a human. 

While the media headlines about the potential of the gene therapy to cure HIV are misleading and extremely premature (at best), there are unique aspects to the American Gene Technologies approach that suggest it may hold promise and deserves testing in trials. 

A considerable amount of prior gene therapy research in HIV has focused on protecting CD4 T cells from infection by the virus. HIV targets these cells, which are a critical component of the immune system. In the absence of treatment, loss of CD4 T cells due to HIV eventually leads to life-threatening immune deficiency.

A problem for gene therapies is that it is impossible to introduce protective genetic modifications into all the billions of CD4 T cells in a person’s body (at least with current technologies). The best-known HIV gene therapy approach, developed by the company Sangamo Therapeutics, was only able to modify a small proportion of the CD4 T cells in trial participants (the therapy aimed to knock out the CCR5 co-receptor that most HIV strains use to gain entry into CD4 T cells). 

Results from Sangamo’s studies showed that some participants had significant increases in CD4 T cell counts, but when antiretroviral therapy (ART) was interrupted no consistent control of HIV viral load was observed. One participant has reported remaining off ART with a low viral load, but details are lacking, and this outcome was unusual. 

The American Gene Technologies approach has similarities, but there is a twist. The company is focusing on trying to introduce protective genetic modifications into only the subset of CD4 T cells that are capable of recognizing and responding to HIV (called HIV-specific CD4 T cells).

Under normal circumstances, the CD4 T cells that specifically recognize and respond to a virus – such as influenza, for example – play a leading role in coordinating other components of the immune system to control viral replication and eliminate virus-infected cells. But HIV is known to preferentially infect HIV-specific CD4 T cells, leaving the immune system leaderless in its efforts to deal with the virus. 

The goal of American Gene Technologies gene therapy is to create a population of HIV-specific CD4 T cells that is protected from HIV infection. A preparatory study that involves isolating HIV-specific CD4 T cells from people with HIV has been ongoing since July 2017. 

The hope is that when ART is interrupted, the genetically modified HIV-specific CD4 T cells will be able to coordinate a strong immune response to the virus, leading to control of viral load without further treatment. Part of the rationale relates to observations that rare individuals who control HIV viral load without ART typically have strong and functional HIV-specific CD4 T cells. 

As part of this effort, American Gene Technologies will collaborate with GeoVax, a company that manufactures an experimental therapeutic HIV vaccine. The aim is to try to boost the numbers of gene-modified HIV-specific CD4 T cells by administering the vaccine to study participants. If the trial receives the green light from the FDA and proceeds, it will represent the first time an HIV gene therapy has been combined with a therapeutic HIV vaccine. 

While there is a good theoretical basis for pursuing this research, there is no direct evidence as yet that it will lead to a cure or even a temporary remission of HIV infection. Unfortunately, this major caveat is not conveyed by most of the current media coverage. 

There are also a variety of possible reasons why the theory might not pan out. In order to have an effect, gene-modified HIV-specific CD4 T cells would likely need to recognize diverse HIV variants present in the person being treated. Furthermore, the process by which the immune system launches virus-specific CD4 T cells into action involves interactions with other immune cells that might be compromised by HIV, particularly dendritic cells. The location where these interactions take place – the lymphoid tissue, which acts as the immune system's command center – can be scarred and damaged in people with long-term HIV infection (referred to as lymph node fibrosis). 

The bottom line is that only clinical trials can answer the question of whether the American Gene Technologies gene therapy is capable of producing any beneficial effects in people with HIV. It’s encouraging that there is progress toward the first trial, and a collaborative agreement with researchers at the National Institute of Allergy and Infectious Diseases indicates that the approach is being taken seriously. But there is no way of knowing if it might lead to an HIV cure. 

July 2019

Story:  HIV eliminated from the genomes of living animals

Examples of media coverage: 

  1. For the First Time, Researchers Eliminated HIV From the Genomes of Living Animals - TIME, July 2, 2019
  2. Scientists eliminate HIV in the entire genome of lab mice for the first time ever: Breakthrough paves the way to a human cure - with clinical trials set to start next year - Daily Mail, July 2, 2019
  3. Have mice really been cured of HIV using CRISPR gene editing? - New Scientist, July 2, 2019
  4. CRISPR gene-editing ‘eliminates’ HIV in some mice. What does it mean for humans? - PBS Newshour, July 2, 2019

Original sources:

  1. Journal article: Sequential LASER ART and CRISPR Treatments Eliminate HIV-1 in a Subset of Infected Humanized Mice - Nature Communications, July 2, 2019
  2. HIV eliminated from the genomes of living animals - Temple University Health System Press Release, July 2, 2019

TAG's commentary: Many different news outlets have published articles about a study published in Nature Communications on July 2nd, which reports the possible elimination of HIV from a small number of humanized mice. The research involved the use of a gene-editing technique, CRISPR/Cas9, which has been designed to try to remove HIV from infected cells. The intent is to perform what might be considered a sort of genetic surgery, slicing HIV’s genetic code out from where it has integrated into the genetic code of an infected cell. 

The research group of Kamel Khalili at Temple University is developing the approach, and they have previously generated headlines after publishing preliminary results (see prior Media Monitor entries on the topic). Khalili has also founded a company, Excision Biotherapeutics, which aims to commercialize the technology.

The latest experiments involved combining a CRISPR/Cas9 construct targeting HIV with a souped-up form of antiretroviral therapy called LASER ART (sequential long-acting slow-effective release antiviral therapy), invented by study co-author Howard Gendelman and colleagues at the University of Nebraka.

The treatments were tested in a humanized mouse model—the mice are bred to be immune deficient, then have their immune systems reconstituted with transplanted human cells, which allows them to be infected with HIV (the virus cannot infect mouse cells). Notably, these models are imperfect because the human cells are eventually rejected as foreign, and don’t necessarily behave exactly how they would in the human body. 

Out of a total of 23 humanized mice that received both LASER ART and CRISPR/Cas9 over the course of three different experiments, nine did not show evidence of HIV viral load rebound when LASER ART was stopped. HIV genetic material could also not be detected in multiple tissue samples from eight of the nine non-rebounders, leading to the claim that the virus may have been eliminated in these cases. In contrast, all animals that received LASER ART without CRISPR/Cas9 did experience HIV viral load rebound after LASER ART cessation. 

The results appear encouraging, but there are still multiple reasons to be cautious about concluding that the work “paves the way to a human cure” as some headlines have stated. 

Perhaps most important, it is not yet known if CRISPR/Cas9 targeting HIV can be safely administered to people. 

A primary concern is the possibility of “off-target” effects, a scenario in which the CRISPR/Cas9 technology inadvertently edits and damages human genes. The researchers have not uncovered any significant off-target effects so far, but it’s a technically daunting task to assess the entire genetic code for evidence of problems. 

Delivering CRISPR/Cas9 to all the cells in the human body that might be infected with HIV represents a major challenge. The delivery vehicle used in the new humanized mouse study was an adeno-associated virus (AAV) vector. AAVs are not known to cause harm and are a popular delivery method for gene therapies. However, the efficiency with which they might target CD4 T cells—the main location of persistent HIV in people on ART—is unclear. Indeed the AAVs used in this study would actually enter many cells in the body beyond HIV-infected CD4 T cells, raising issues of safety and off-target activity.

Adding to the challenge, CRISPR/Cas9 is derived from bacteria, meaning that the human body is likely to treat it as foreign and mount an immune response against it. Studies have found that most people have pre-existing immune responses to Cas9 due to exposure to the bacteria Staphylococcus aureus and Streptococcus pyogenes. Using AAV as a delivery vehicle may also promote the development of immunity against the CRISPR/Cas9 cargo—this type of problem stymied the first attempt to use AAV to deliver an anti-HIV broadly neutralizing antibody in a clinical trial.  

The genetic variability of HIV in humans means that CRISPR/Cas9 will need to target parts of the virus that mutate the least in order to be broadly effective across different populations (and recognize all the viral variants present in an individual). In the humanized mouse study, animals were infected with laboratory HIV strains. 

Some scientists have expressed concern over what might happen if a cell harbors more than one copy of HIV. Rather than removing a single virus, the CRISPR/Cas9 technology could theoretically make cuts at sites in each HIV copy, causing the removal of all the cell’s genes that were in between. This would likely damage the cell, although the exact consequences would be unpredictable. 

There are also some uncertainties regarding the technical aspects of the published study—as author Howard Gendelman notes in the Daily Mail article, the paper was rejected by “many different journals.” While Gendelman claims this was just due to skepticism about the results, it is likely that the independent scientific peer reviewers who recommended rejection had specific concerns about how the research was conducted and/or presented. 

Notably, no other research groups have yet presented any similar results with CRISPR/Cas9 in animal models (at least to our knowledge). Independent confirmation would offer reassurance about the reliability of the findings. 

The next step prior to human trials is conducting experiments in macaque monkeys infected with SIV (HIV’s counterpart in monkeys). Some preliminary results were presented in March 2019 at the Conference on Retroviruses and Opportunistic Infections (CROI), and were covered in detail on TAG’s HIV Basic Science, Vaccines, and Cure Project Blog. 

It will be critical to test whether targeting SIV with AAV-delivered CRISPR/Cas9 in macaques treated with antiretroviral therapy can prevent viral load rebound when therapy is stopped (as appeared to occur in some of the humanized mice). A successful outcome in the SIV/macaque model would offer far more convincing support for the potential efficacy of the approach than results in humanized mice. 

A problem to be aware of with the current media coverage is that many of the headlines are inaccurate, e.g. TIME: “For the First Time, Researchers Eliminated HIV From the Genomes of Living Animals” and the Daily Mail: “Scientists eliminate HIV in the entire genome of lab mice for the first time ever.” The source of the confusion is the Temple University press release, which was titled  “HIV eliminated from the genomes of living animals.” This is not true. Mice cannot be infected with HIV, so the virus was not eliminated from their genomes. The claim of HIV elimination only applies to the human cells that the mice had been transplanted with, and the genomes of those human cells belong to the human they came from, not the mice. 

The Temple University research group and Excision Biotherapeutics hope to start human trials within a year or so, but that is likely to depend both on results in macaques and whether regulators at the U.S. Food and Drug Administration decide there is sufficient evidence that participants would not face undue risks. 

October-November 2018

Story: Claims that “Gammora” Represents a Potential HIV Cure

Examples of media coverage: 

  1. HIV cure? Major breakthrough made in eradicating deadly virus: 'Beyond our expectations'  - Daily Star, November 1, 2018
  2. New drug could cure HIV/Aids - Uganda Daily Monitor, November 7, 2018
  3. Maker of 'potential HIV cure' moves to calm frenzy over new drugHealth24, November 7, 2018

Community-based articles and responses: 

  1. Gammora does not cure HIV – Roger Pebody and Gus Cairns, AIDSMap, November 6, 2018
  2. Company with false HIV 'cure' admits trial was not registered with regulatory body - Sanele Ngcobo, Bhekisisa, November 9, 2018
  3. Reports of Imminent HIV Cure, Once Again, Are False - Benjamin Ryan, POZ Magazine, November 12, 2018

Original source:

  1. Press release: Zion Medical Announces Results of First Human Clinical Trial of HIV drug Gammora, Offering Potential Cure  – Zion Medical, October 31, 2018

TAG's commentary: This announcement relates to a peptide (protein fragment) that was covered on this media monitor page in 2016, when it was claimed to represent a possible HIV cure based just on results in a laboratory dish. But the one published laboratory study did not offer evidence that the approach might cure HIV infection. 

The peptide is reported to alter the HIV life cycle in a way that causes more copies of the virus genome to integrate into the genetic code of the cells that it infects. The integration of multiple copies of HIV is said to promote the death of the virus-infected cell by apoptosis (cellular suicide). 

On October 31, 2018, Zion Medical, a small biotech company based in Israel, issued a press release claiming once again that the peptide—which they have named Gammora—is a “potential cure.” Again, the evidence does not support the claim. 

The press release offers a vague description of results from a 9-person clinical trial conducted at the Dr. Ronald Bata Memorial Hospital in Entebbe, Uganda. According to this description, administration of the peptide led to decreases in HIV viral load compared to baseline levels in individuals who were not receiving antiretroviral therapy. 

Subsequent addition of the antiretroviral lopinavir/ritonavir is said to have caused a further reduction in viral load. In some stories this is mistakenly presented as 99% of HIV being eliminated or the peptide being 99% effective - what is being described is a 99% reduction in HIV viral load, which is seen with standard antiretroviral drug combinations. The press release states there was control group of individuals who received lopinavir/ritonavir without the peptide, but does not say if viral load reductions were any different in this group. 

The press release claims that the peptide “has the potential to cure HIV infected patients, by destroying all cells carrying the HIV virus-genome.” This is false. 

Even if the peptide does kill HIV-infected cells by the mechanism of action that has been ascribed to it, this would not affect the latent HIV reservoir, which is considered the major obstacle to achieving a cure. The latent HIV reservoir is made up of cells carrying the HIV virus genome in an inactive state, and the purported mechanism the peptide would only affect cells in which HIV is actively replicating. 

The public relations contact on the Zion Medical press release relayed responses from the company to some questions posed by TAG. 

When asked how the peptide would be capable of “destroying all cells carrying the HIV virus-genome,” the company offered a convoluted reply falsely stating “there is a specific known marker” for cells containing latent HIV (no such marker has been discovered) that could allow them to target the cells with a gene therapy approach (a lentiviral vector) that they have not even yet tested against HIV: 

“The mechanism can suggest either that latent cells can be destroyed if another [HIV] virus will infect this cell (in naïve patients) or if not, we will need to introduce the latent cells with lentiviral particles which are targeted to those cells (there is a specific known marker) and the LV [lentiviral vector] will ‘replace’ the HIV.”

So, even by the company’s own assessment, the peptide is not capable of “destroying all cells carrying the HIV virus-genome” as claimed in the press release. And their idea for addressing the latent HIV reservoir is based on a misapprehension that a marker of the reservoir exists that would allow it to be targeted by a gene therapy (a gene therapy not tested in the clinical trial, and seemingly not yet tested against HIV at all).  

In simple terms, what this means is that the Zion Medical press release stating their peptide is a potential HIV cure is egregiously false. The press release led directly to multiple media stories and social media commentaries that were equally erroneous and misleading. 

Another aspect to this announcement that remains unclear is how the clinical trial in Uganda was regulated. The trial is not listed among research authorized by the Uganda National Drug Authority. The company states that the Ugandan Ministry of Health approved the trial, but they are not a regulatory agency charged with assessing whether an experimental candidate is safe to test in people. 

The Dr. Ronald Bata Memorial Hospital in Entebbe is operated by the Uganda Special Forces Command (SFC), and an article in the Uganda Daily Monitor contains a quote from spokesperson Jimmy Omara stating that the SFC was involved, but provides no further details. 

In an article for Bhekisisa, Sanele Ngcobo reports that the trial was not registered with a regulatory agency. Hopefully further information will emerge about the conduct of the trial. 

False claims of HIV cures exploit the hopes people have that an HIV cure will be developed, to generate publicity. Such claims often prove divisive, because a strong desire to believe they might be true can lead people to attack anyone offering evidence-based refutations.  The fact that HIV is still so stigmatized can make dangling false hope of eliminating the virus into a form of psychological torture, and there have been reports in the past that claims of cures have caused some people to abandon standard HIV treatment. 

No reputable scientist or company should ever engage in this type of hype. 

November-December 2017

Story: Cancer drug leads to 'drastic decrease' in HIV infection in lung cancer patient

Examples of media coverage: 

  1. ​​Lung cancer drug may be early clue in hunt for HIV cure - The Independent, November 30, 2017
  2. Cancer drug offers tantalising hope for HIV cure - The Guardian, November 30, 2017
  3. HIV breakthrough as cancer drug could hold secret to curing the virus - The Daily Mirror, December 1, 2017
  4. Bristol-Myers Cancer Drug Opdivo Shows Surprising HIV Impact - Bloomberg News, December 1, 2017
  5. HIV Cure? Lung Cancer Drugs 'Shock and Kill' HIV in French Patient - Newsweek, December 1, 2017

Original source(s):

  1. Scientific journal letter: Drastic decrease of the HIV reservoir in a patient treated with nivolumab for lung cancer - Annals of Oncology, December 1, 2017
  2. European Society for Medical Oncology Press Release: Cancer drug leads to 'drastic decrease' in HIV infection in lung cancer patient - November 30, 2017

TAG's commentary: This story relates to a published case report about an HIV+ individual who received a new type of immunotherapy to treat his lung cancer. Because there is just one person involved, no conclusions can be drawn from the results - this important point is made by several scienists who are quoted in the media coverage.

The individual in question is reported to have experienced a reduction in levels of HIV DNA in their bloodstream when they were measured 120 days after starting the immunotherapy. HIV DNA levels are a rough measurement of the HIV reservoir that persists despite antiretroviral therapy (ART). The HIV reservoir is considered the major barrier to achieving a cure, and there is a lot of research into approaches that might reduce the reservoir size.

The decrease in HIV DNA levels was from 369 copies per million cells to 30 copies per millions cells, which is an approximately 92% reduction. The individual has remained on ART the whole time.

The case was orginally reported in a poster at the IAS 2017 conference this past July, and--importantly--the poster also describes a second HIV+ individual who received the same immunotherapy and saw a slight increase in HIV DNA levels measured after 30 days (this second individual is mentioned in the press release and several of the media articles, and was described in a published letter in the journal AIDS in April 2017).

At the HIV Cure and Cancer Forum that took place immediately ahead of the IAS 2017 conference, Tim Henrich also described three HIV+ individuals who had received the same type of cancer immunoterapy and did not experience any consistent changes in HIV DNA levels (see abstract OA3-1 in the Forum's abstract book). So while this newly published case report has now drawn considerable media coverage, the individual appears to represent an outlier (at least based on information available so far). 

A 92% reduction in HIV DNA levels is larger than has been reported with any other interventions except for stem cell transplants for cancers (which can only be used in severe life-threatening cancers because there is a 20-30% risk of death). The largest reduction in HIV DNA that had been described previously was around 67–84% in subset of four people participating in a clinical trial of panobinostat, a cancer drug belonging to the HDAC inhibitor class. Notably, this reduction was only associated with a slight delay in HIV viral load rebound when ART was interrupted.

Studies using an approach called mathematical modelling have suggested that a reduction in the HIV reservoir of more than 99.99% would be needed to have a chance of preventing HIV viral load rebound for life. It has also been reported that only clinical trials involving between 40 and 150 HIV+ individuals can "reliably estimate the reservoir-reducing potential of a new therapy," which underscores the difficulty of trying to understand a result obtained in one person. 

The cancer immunotherapy given to the individual in the case report was nivolumab (brand name Opdivo). Nivolumab is an antibody that targets PD-1, a receptor that can appear on the surface of T cells that have become exhausted and dysfuctional. Blocking PD-1 with nivolumab can revive the anti-cancer activity of T cells, and this is thought to contribute to significant efficacy in treating a number of different cancers.

Studies have also reported that blocking PD-1 can revive T cells targeting HIV in a laboratory dish, as well as potentially stimulating virus production by the HIV reservoir (making the reservoir vulnerable to T cell attack). The authors of the new case report suggest that this dual mechanism may explain the reduction in HIV DNA levels that they observed. 

The main problem with nivolumab and similar anti-cancer immunotherapies (known as immune checkpoint inhibitors) is that they can also stimulate T cells that recognize body tissues, causing autoimmunity (see the warning and precautions on the nivolumab label). This is why they are currently being almost exclusively studied in HIV+ individuals who need immune checkpoint inhibitor treatment for cancers (see the immune checkpoint inhibitor section of TAG's cure-related clinical trial listing). Only one current trial is evaluating an anti-PD1 antibody in HIV+ people without cancer, and it is administering just a single dose. 

Results from the ongoing trials of immune checkpoint inhibitors in HIV+ individuals with cancers are likely to start being reported next year. Those results will provide a clearer picture of any effects on the HIV reservoir, and should reveal if there are lessons that can be learned to help develop an HIV cure. 

Amongst the media coverage, The Independent in the UK offers the most realistic headline: "Lung cancer drug may be early clue in hunt for HIV cure." Tim Henrich's presentation regarding three HIV+ recipients of anti-PD1 antibodies who did not experience HIV DNA declines does not appear to be mentioned in any of the articles. The worst mistake appears to belong to The Daily Mirror, whose article erroneously states that nivolumab "has no known side effects."

December, 2016-February, 2017

Story: Nigerian Scientists Claim To Have Discovered Complete Cure For HIV/AIDS

Examples of media coverage: 

  1. Nigerian Scientists Claim To Have Discovered Complete Cure For HIV/AIDSNigerian Bulletin, December 13, 2016
  2. Michael Okpara varsity discovers new cure of HIV/AIDS - Daily Trust, February 1, 2017
  3. NACA, NCDC fault claims of HIV curePunch Newspapers, February 6, 2017
  4. Professor to ‘harmonise findings’ on HIV/AIDS cure claimsThe Guardian, February 10, 2017

Original source(s):

  1. Journal article: HIV/AIDS Recovery Rates in Male and Female Patients, Treated with Medicinal synthetic Aluminum-magnesium silicate - British Journal of Medicine and Medical Research, November 24, 2016

TAG's commentary: This story relates to a professor of veterinary medicine named Maduike Ezeibe at the Michael Okpara University of Agriculture in Nigeria, who has been stating that he has developed “medicinal synthetic aluminum-magnesium silicate” (MSAMS) as a cure for HIV for several years now. The latest media coverage was prompted by the publication of a paper in what appears to be a very untrustworthy, little-known scientific journal (the “British Journal of Medicine and Medical Research”). 

Ezeibe is the lead author on the paper, and he claims to have “terminated” HIV infections using MSAMS combined with a nutritional supplement named Immunace Extra-Protection®. The paper is problematic for many reasons. Clinical trials in Nigeria require review and approval by the Nigerian National Health Research Ethics Committee (NHREC), but according to Ezeibe the ten HIV-positive individuals described in the paper were administered MSAMS by their personal doctors, who also performed monitoring. Worse, it is clear that Dr. Ezeibe does not understand how ethical human research is conducted – in previous papers he has written that participants were recruited by telling them that MSAMS is safe and effective and could cure HIV infection:

“Journal publications which reported that AMS is a safe medicine and those that reported antiviral effects of the MSAMS were used to counsel HIV/AIDS patients. Patients who became convinced that the Antivirt® is safe and can lead to cure of HIV/AIDS, applied through their physicians, for the clinical trial.”

The whole purpose of research is to discover if an experimental intervention is safe and effective, and it is a massively serious ethical violation to inform potential research participants that the intervention works. 

The recent paper reports that MSAMS was administered to ten people (with no control group) and makes implausible claims about viral load decreases, CD4 T cell increases and participants rapidly becoming HIV seronegative (antibodies persist for long periods even if the antigen that induced them are cleared, this has been documented in the lone individual that rigorous studies have indicated is cured of HIV infection, Timothy Ray Brown). 

The journal does provide a history of how the paper was reviewed, and—to their credit—one reviewer writes: 

"The authors presented a paper where they have cured patients with HIV with an experimental drug. The authors should send us evidence (exams, documents proving that the research passed through ethical committees and clinical drug tests approval)."

However, the journal published the paper anyway. TAG’s email to journal editor Dr. Younes Smani asking why the paper was published did not receive a reply. 

The media reports have prompted a response from the National Agency for the Control of Aids (NACA) and Nigeria Centre for Disease Control (NCDC), who pointed out that the research appears to have been performed improperly and that there is no evidence that MSAMS can cure HIV infection. The National Health Research Ethics Committee (NHREC) of the Federal Ministry of Health has also stated that they are now investigating Ezeibe’s research – a report is pending, but the Minister of Health, Professor Isaac Adewole, has already stated: "at the National Health Research Committees level, there is no evidence that this researcher sought and obtained ethical approval.”

From the information available online, it seems that synthetic aluminum-magnesium silicate is primarily used as an additive caking agent for food and cosmetic products. There is some scientific literature relating to its use as a drug delivery vehicle. Aside from Ezeibe’s publications, there is no apparent literature suggesting that it has antiviral properties. 

What is even more distressing about the situation is the Deputy Vice Chancellor of Michael Okpara University of Agriculture, Nbibisi Iwe, has been quoted saying that they are being inundated with inquiries about MSAMS and may even be providing it to people: 

“As one of the managers of the university, I know that there is a lot of requests coming from all over the places to the university for assistance and people have been receiving this assistance. And they have been attesting to it that this very assistance is useful to them.’’

The controversy has also prompted some unfortunate opinion pieces arguing that there should be less concern about the ethical conduct of the research and more acceptance of the possibility that a cure has been developed by a Nigerian researcher; these pieces fail to grasp that ethics are an integral part of the rigorous scientific evaluation of whether an intervention works. Any claim to have developed a cure for HIV infection must be backed by high quality, reproducible evidence, and that is clearly not the case here. To make a claim without such evidence is a grotesque exploitation of the hopes of many millions of people. It is unfortunate that Ezeibe’s claims have become entangled with issues of Nigerian national pride – there is no question that Nigerian scientists are capable of breakthroughs, but—as is the case for any scientist—claims of breakthroughs must be supported with compelling, verifiable evidence. 

This posting will be updated when the complete report from the Federal Ministry of Health becomes available. 

Update May 3, 2017: The Lancet Infectious Diseases has posted a news story reporting on Ezeibe’s claims:

Claims of a cure for HIV come under fire (access free with registration) - Talha Burki, Lancet Infectious Diseases, May 2017

Sadly it is clear that Ezeibe, despite his academic credentials, is no different than other charlatans who have promoted false HIV cure claims. This is further confirmed in an interview he gave, where he makes it clear he is distributing his MSAMS substance widely and believes himself to be on a mission from God. The suggesttion that he is advising some HIV+ people to stop antiretroviral therapy is frightening and infuriating. Depending on exactly where and how MSAMS is being distributed, what Ezeibe is doing may be breaking laws. 

The British Journal of Medicine and Medical Research has removed Ezeibe's paper from their website and replaced it with a message stating that an investigation is being conducted. 

November 2016

Story: Israeli scientists see breakthrough in AIDS cure

Examples of media coverage: 

  1. Israeli scientists see breakthrough in AIDS cureThe Times of Israel, November 1, 2016
  2. Israeli researchers offer some hope for HIV carriersArutz Sheva 7, November 1, 2016
  3. Israeli research successful in identifying possible HIV, AIDS cureThe Jerusalem Post, November 2, 2016

Original source(s):

The media articles describe results of a new study that do not appear to have been published, and it’s not clear if they were presented at a conference. The researchers have not responded to emails asking if the results have been published or presented. A previous study describing the approach is available online in the open access journal AIDS Research & Therapy, which charges authors to publish articles and has unusually rapid peer review (all papers have to be reviewed within two weeks):

Specific eradication of HIV-1 from infected cultured cells - Aviad Levin, Zvi Hayouka, Assaf Friedler and Abraham Loyter, AIDS Research and Therapy, August 19, 2010

TAG's commentary: These stories are based entirely on results obtained in laboratory dish experiments. The researchers have developed peptides (fragments of proteins) that enhance the ability of HIV to integrate its genes into the genome of the cells that it infects. Normally only one or two copies of HIV integrate into a single infected cell, but the peptides are reported to increase this number. In the published study, adding the peptides to cultured HIV-infected cells in a laboratory dish led to an increase in viral replication which was followed, about a week later, by increased death of infected cells due to apoptosis (cellular suicide). The combination of the peptides with a protease inhibitor led to a more rapid onset of the death of HIV-infected cells.

The recent news articles suggest that a similar experiment has now been conducted using cells sampled from HIV-positive individuals instead of the laboratory cell lines employed in the published paper. If the stories are accurate, similar effects were seen, with the approach reducing the number of HIV-infected cells over time in a laboratory dish.

While some of the headlines claim this may be a step toward an HIV cure, this claim is massively premature – it is not yet known if the approach could be used in people, or if there would be a similar effect on the number of HIV-infected cells. Importantly, it’s not clear how the approach would work against the HIV reservoir, which presents the biggest obstacle to curing HIV infection.  The HIV reservoir consists of cells containing integrated virus that is latent (inactive) and the peptides appear to work by promoting the integration of viruses that are actively replicating. Thus there is no obvious mechanism by which the combination of the peptides with antiretroviral therapy would affect the latent HIV reservoir in the absence of an additional strategy to try and activate the latent HIV. Furthermore, studies assessing whether the peptides can be safely delivered to any animal, let alone humans, do not appear to have been conducted as yet.

Hopefully the study being reported in these news stories will be published soon, allowing a more thorough assessment of the results. 

October 2016

Story: British scientists on brink of HIV cure

Examples of media coverage: 

  1. British scientists on brink of HIV cure (headline now corrected to "British scientists hopeful for HIV cure") – The Sunday Times, October 2, 2016 (registration required)
  2. HIV cure close after disease 'vanishes' from blood of British man (now amended to the still inaccurate "HIV cure possible after disease becomes undetectable in blood of British man") - The Daily Telegraph, October 2, 2016
  3. Why talk of a cure for HIV is premature - Fergus Walsh, BBC News, October 3, 2016 (an accurate story written with the cooperation of the researchers). 

Community-based responses and articles: 

  1. Media reports of a British HIV cure 'breakthrough' are premature - Keith Alcorn, AIDSMap, October 3, 2016
  2. U.K. Papers Erroneously Report, Yet Again, That an HIV Cure Is Near - Ben Ryan, POZ Magazine, October 3, 2016
  3. No Proof of New HIV Cure, Despite Headlines -- Here's What We Know - Roger Pebody,, October 3, 2016
  4. Reports Of UK HIV Cure Are Misleading - Miranda Smith, Doherty Institute/NAPWHA HIV Cure Website, October 4, 2016
  5. 'Infuriating': People With HIV, Doctors, Advocates Speak Out on Bad 'HIV Cure' Reporting - JD Davids,, October 4, 2016

Original source(s):

Unknown, the original Times story appears to be based on interviews with researchers and a single study participant.

TAG's commentary: These stories, and particularly the headlines, are highly misleading and inaccurate. The subject matter is an ongoing clinical trial in the UK that is not expected to cure anyone of HIV infection. Known as the RIVER study, it represents an important first exploration of the combined effects of a therapeutic HIV vaccine and an HDAC inhibitor (vorinostat) on the HIV reservoir in individuals who started antiretroviral therapy (ART) very soon after becoming infected.

The stories state that one participant has undetectable HIV viral load in their blood but this is normal for individuals on antiretroviral therapy. No measurements of the HIV reservoir have yet been performed. The journalist appears to have interviewed the study participant and misunderstood the significance of undetectable viral load, a misunderstanding that has now beem amplified in secondary media reporting. 

The current best approach for assessing whether HIV is still present is to interrupt ART, and the researcher Sarah Fidler makes it clear in the articles that this is not yet being considered. As some of the more accurate media coverage explains, even if HIV remains undetectable after an ART interruption long-term follow up is required because there have been several cases where viral load remained undetectable for months or--in the case of the Mississippi baby--years before rebounding. 

recent study that combined a therapeutic HIV vaccine with an HDAC inhibitor revealed some evidence of a slight decline the HIV reservoir, but there was no effect on viral load rebound when ART was interrupted. Participants in this study had not recently acquired HIV. 

The bottom line is that it appears extremely unlikely that anyone participating in the RIVER trial will be cured, but the information learned is expected to make a contribution to the ongoing effort to develop a cure. Results are expected in 2018.

As has happened in the past, an effort is now underway to secure corrections to the Times and Telegraph articles.

Additional resources:

Information on the RIVER trial from the CHERUB (Collaborative HIV Eradication of viral Reservoirs: UK BRC) website. entry for the RIVER trial. 

April 2016

Story: Cure for HIV possible “within three years”

The Daily Telegraph article and examples of the media coverage that followed it:

  1. Cure for HIV possible within three years as scientists snip virus from cells – The Daily Telegraph, April 1, 2016. Update April 6, 2016: After receiving complaints, The Daily Telegraph has creditably responded by editing the headline and first paragraph to remove the claim that the approach may cure HIV infection "within three years" or "a few years." 
  2. HIV Could Be Cured Within Three Years - Fortune, April 1, 2016
  3. Cure for HIV reportedly 3 years away -, April 2, 2016  

Examples of initial media coverage:

  1. Scientists remove HIV-1 from genome of human immune cellsUnited Press International, March 21, 2016
  2. Temple researchers snip HIV from infected cells, suggesting a cure is possible -, March 23, 2016

Community-based responses and articles: 

  1. Media Outlets Falsely Claim That a Cure for HIV May Be Only Three Years Away - Benjamin Ryan, POZ Magazine, April 4, 2016
  2. Snipping the HIV Genome Out of Latently Infected Cells – TAG’s Michael Palm HIV Basic Science, Vaccines, and Cure Project Blog, March 23, 2016 
  3. Gene therapy snips HIV out of infected cells and makes uninfected cells resistant - Gus Cairns, AIDSMap, March 30. 2016

Original source(s):

  1. Scientific journal article: Elimination of HIV-1 Genomes from Human T-lymphoid Cells by CRISPR/Cas9 Gene Editing - Scientific Reports, March 4, 2016
  2. Temple University Press Release: Scientists at Lewis Katz School of Medicine at Temple University Eliminate HIV-1 from Genome of Human T-Cells - March 21, 2016
  3. Excision BioTherapeutics Inc. Press Release: Use of CRISPR Cas9 Gene Editing Therapeutic Shown to Permanently Inactivate HIV-1 in Patient's Blood for First Time - March 21, 2016

TAG's commentary: The story is about a gene-editing approach designed to try and eliminate HIV from infected cells that was already covered on this page two years ago (the challenges involved in trying to translate the approach into a therapy remain the same as described then). 

The approach is still only being tested in laboratory experiments and it is not yet known if it can be translated into a therapy suitable for administering to people. 

The renewed media attention was caused by the publication of a scientific paper in the journal Scientific Reports (see TAG’s blog post for details), which was promoted by press releases from the research institution, Temple University, and Excision BioTherapeutics, a company the lead researcher Kamel Khalili has founded to try and commercialize the approach (in partnership with Temple). 

The scientific paper was published online on March 4, followed by the press releases on March 21, and received an initial round of media coverage that was reasonably accurate, although somewhat over-optimistic about the immediate prospects for the approach. 

Then, on April 1, The Daily Telegraph published an article claiming that it might be possible to find out whether the approach can cure HIV infection within three years - this is outrageously false. 

Even under the most optimistic scenarios, it is likely to be more than three years before even the first clinical trials are possible (and it is not known yet if human trials will be possible).

In an excellent article for POZ Magazine, Ben Ryan obtained a quote from Kamel Khalili in response to The Daily Telegraph's coverage: “We have made no claim that our technology will cure HIV in three years.” 

Unfortunately, as often happens with attention-grabbing headlines, many other media outlets around the world are now parroting The Daily Telegraph’s false claim that this research may lead to an HIV cure “within three years.”

Sarah Knapton, The Daily Telegraph's Science Editor and author of the article, has so far refused requests to make appropriate corrections. 

Unfortunately this is the second example of irresponsible, misleading coverage of HIV cure research by The Daily Telegraph. Such articles exploit people’s hopes for an HIV cure in order to generate web traffic and social media attention, a tactic that is reprehensible and unethical. In that prior case, however, The Daily Telegraph did at least eventually correct the errors when they were brought to their attention (see this POZ Magazine article by Ben Ryan and the updates at the end of this blog post). Hopefully this latest erroneous article will eventually be corrected as well. 

Update April 6, 2016: As noted above, The Daily Telegraph has thankfullly now responded by editing the headline and first paragraph to remove the mistaken claim that the approach may cure HIV infection "within three years" or "a few years."

October 2015

Story: New Breakthrough May Lead to HIV Relapse Cure
Examples of media coverage:
  1. New Breakthrough May Lead to HIV Relapse Cure - Indo-Asian News Service, October 11, 2015
  2. HIV breakthrough could lead to a CURE: Scientists identify markers on immune cells that 'predict who can stop drug therapy and stay well'Daily Mail, October 9, 2015
  3. Doctors report major breakthrough in understanding virus that causes AIDSNew York Daily News, October 9, 2015
Original sources:
  1. Scientific journal article: Immunological biomarkers predict HIV-1 viral rebound after treatment interruption - Nature Communications, October 9, 2015
  2. Press release: HIV discovery – biomarkers predict virus return when treatment is stoppedUniversity of New South Wales, October 9, 2015
TAG's commentary: The subject of these news stories is a study that identified an association between levels of certain immune system markers in the blood and the time it took for HIV viral load to rebound after an antiretroviral therapy (ART) interruption. 
In general, the news stories do a reasonable job of explaining that the researchers are hoping their results can contribute to the cure research effort by helping predict whether an individual will be able to control viral load after ART is interrupted. This could assist in selecting individuals best suited for participation in cure research trials involving ART interruption. Measurement of the immune system markers that were associated with delayed viral load rebound might also help show if an experimental therapy is having a positive effect. 
Some of the news headlines have suggested that the study results may lead directly to an HIV cure, but this is an inaccurate exaggeration. The UK’s NHS Choices website, which specializes in addressing inaccurate media stories, published an excellent article countering the inaccurate headlines and providing a more realistic perspective on the research. 

May 2015

Story: Gilead Sciences May Have Found A Cure For HIV

Examples of media coverage:

  1. Gilead Sciences (GILD) May Have Found A Cure For HIV!CNA Finance, May 18, 2015
  2. This Experimental Drug Could Finally Cure HIV - Motley Fool, May 18, 2015‎

Original source:

Unknown, possibly a Gilead Sciences presentation to investors, although it is highly unlikely the company claimed that the drug may cure HIV.

TAG's commentary: For reasons that are unclear, two websites that cover financial news have published wildly erroneous stories suggesting the company Gilead Sciences may have discovered a cure for HIV.

The drug in question is named GS-9620, and it has shown some promise in a small study involving monkeys infected with SIV (HIV’s simian equivalent). Administration of GS-9620 to macaques on antiretroviral therapy (ART) appeared to slightly reduce levels of the latent SIV reservoir, but it did not lead to a cure. When ART was interrupted, viral load rebounded in all animals, and there was no evidence that the viral load rebound was slower or delayed in macaques that received GS-9620. However, when viral load stabilized (described as the viral load “set point”), levels were somewhat lower in GS-9620 recipients.

These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) earlier this year, and a webcast of the presentation is available online. Many news outlets and community-based organizations (including TAG) covered the presentation at the time (e.g. see articles from AIDSMap and Project Inform).

Evidence suggests GS-9620 may have a dual mechanism of action, both inducing production of virus by latently infected CD4 T cells and enhancing immune responses (such as natural killer cells), that could potentially contribute to clearing the infected CD4 T cells. GS-9620 interacts with toll-like receptor 7, an immune cell receptor involved in the recognition of pathogens, and has been studied in people with hepatitis B and reported to be safe.

An initial phase I trial in HIV-positive individuals is now underway and results should help shed light on whether GS-9620 might be able to reduce the latent HIV reservoir and potentially contribute to achieving a cure. But yesterday’s headlines suggesting that GS-9620 might be a cure for HIV are completely incorrect and irresponsible. 

March 2015

Story: FDA Gives HIV 'Functional Cure' Go-Ahead For Human Trials

Examples of media coverage:

  1. FDA Gives HIV 'Functional Cure' Go-Ahead For Human Trials: Functional HIV Cure Step Closer To Reality With FDA Approval Of Clinical Human TrialsMedical Daily, March 10, 2015
  2. Study of potential HIV 'cure' wins FDA nod - San Francisco Business Times, March 3, 2015

Original source:

  1. Press Release: CIRM-funded Clinical Trial Aimed at Blocking HIV/AIDS in People Gets the Go Ahead - California Institute for Regenerative Medicine, March 3, 2015

TAG's commentary: These stories, which have been widely shared on social media (particularly the Medical Daily article), were prompted by a news release issued by the California Institute for Regenerative Medicine (CIRM). CIRM is supporting a team at the City of Hope in Los Angeles that plans to genetically modify stem cells to render them resistant to HIV, and test whether administration of these stem cells to HIV-positive individuals has a therapeutic effect.

The press release announced that the US Food and Drug Administration (FDA) has given approval for the conduct of a clinical trial in HIV-positive individuals experiencing a poor response to antiretroviral therapy (ART).

The trial will extract stem cells from the study participants, modify them with an approach developed by Sangamo BioSciences that aims to prevent expression of the CCR5 co-receptor that most HIV strains use to infect cells, then reinfuse the stem cells in hopes that they generate HIV-resistant immune cells (particularly CD4 T cells, HIV’s main target). Stem cells are responsible for generating all the different types of immune cells in the body, including CD4 T cells.

Sangamo’s approach has been used in several other clinical trials to modify CD4 T cells that are extracted from study participants and reinfused. The results have shown overall increases in CD4 T cells numbers, and a few participants have shown evidence of some degree of HIV viral load control after an ART interruption, but there have been no cases of a “functional cure” of HIV infection. The term “functional cure” is generally used to refer to a state in which HIV is not eradicated, but completely controlled without ongoing treatment, in a way that prevents the virus from causing any illness.

The problem with the Medical Daily and San Francisco Business Times headlines is that there is no evidence that the plan to deliver gene-modified stem cells will lead to a “cure” or a “functional cure” of HIV. The whole purpose of clinical trials is to assess the effects of an intervention, whereas the headlines mistakenly pre-judge what the effect of the intervention will be.

Previous trials involving transplantation of stem cells that were gene-modified to be resistant to HIV have found that the numbers of HIV-resistant CD4 T cells generated were very low. The new CIRM trial is an encouraging first step toward assessing whether stem cells modified with the Sangamo approach will perform better, but it is unfortunately extremely premature and misleading to describe the approach as a “functional cure” or potential “cure.”

November 2014

Story: Doctors “Cure” HIV Patient with Cord Blood Transplant

Examples of media coverage:

  1. Primer Paciente "Curado" del VIH por un Trasplante de Sangre de Cordón UmbilicalEl Mundo, November 6, 2014
  2. Doctors "Cure" HIV Patient with Blood TransplantLocal: Spain’s News in English, November 6, 2014
  3. HIV Cure News 2014: Barcelona Doctors Believe They've Found Cure to AIDS-Causing VirusLatin Post, November 8, 2014
  4. Spain to Research HIV Cure Using Umbilical Cord BloodEl País, November 10, 2014
  5. HIV Breakthrough! Spain Finds Functional Cure For HIV Virus (Confirmed) - In South Africa Today, July 13, 2015

Original sources:

  1. Press release: La ONT y la SEHH Apuestan por el Trasplante de Sangre de Cordón Umbilical para Erradicar el VIH en Pacientes con Cáncer Hematológico – Ministerio de Sanidad, Servicios Sociales e Igualdad, La Organización Nacional de Trasplantes y la Sociedad Española de Hematología y Hemoterapia, November 6, 2014
  2. Presentation by Rafael F. Duarte at a symposium titled Trasplante de Progenitores Hematopoyéticos Alogénico y Curación de VIH – LVI Congreso Nacional de la Sociedad Española de Hematología y Hemoterapia, November 7, 2014
  3. Abstract by Rafael F. Duarte, et al. (Embargoed until December 10, 2014): Allogeneic Transplantation with CCR5Δ32/Δ32 Cord Blood Hematopoietic Cells in a HIV-Infected Patient– 56th American Society of Hematology Annual Meeting and Exposition, San Francisco, CA, December 6–9, 2014

TAG's commentary: The initial trigger for this story, which first appeared in the Spanish newspaper El Mundo, was a press release issued on November 6 by the National Transplant Organization, the Spanish Hematology and Hemotherapy Society, and the Ministry of Health. The primary focus of the release was the launch of a new research project that aims to provide cord blood stem cells from donors heterozygous for the CCR5Δ32 mutation to HIV-positive people who require stem cell transplants to treat cancers. The hope is that this approach can both treat the cancer and recapitulate the cure of HIV achieved in Timothy Brown (the only individual considered cured of HIV infection to date). But the release also mentions that the approach “succeeded in an HIV patient with lymphoma treated in 2013.” It is the reference to this previously unknown case that has become the focus of news reporting, and unfortunately misinformation has seeped into some of the articles.

The individual, who was treated in Barcelona, survived for only three months after the transplantation procedure due to a recurrence of the lymphoma (a Latin Post article misreports the posttransplant survival as three years). According to one of the researchers involved, HIV became undetectable in blood samples (by multiple tests), but antiretroviral therapy was not stopped and it was never proved that the individual was cured. The El Mundo article states that tissues and cerebrospinal fluid were also analyzed, but this appears to be an error. The potentially encouraging finding for the future is that the cord blood stem cell transplant with the CCR5Δ32 mutation did eventually engraft, although it required an additional cord blood stem cell transplant from a normal donor to assist the process. As with Timothy Brown, the individual was found to have developed an immune system resistant to CCR5-tropic HIV strains as a result of the engraftment of the transplant. The researchers note that a potential advantage of cord blood stem cells is that less stringent genetic matching of donor and recipient is required compared with adult stem cells (Brown’s procedure involved the latter). 

A manuscript about the case has been submitted for publication, so more details will be forthcoming (May 2015 update: the case report is now published in The Lancet HIV). The lead researcher, Rafael Duarte, is due to present at the upcoming 56th American Society of Hematology Annual Meeting and Exposition, and his abstract is available online; however, it is under embargo until after the conference ends.

The media stories that have followed the initial El Mundo report offer examples of how misleading hype can be generated. The Latin Post article is headlined is “Barcelona Doctors Believe They've Found Cure to AIDS-Causing Virus,” and it opens with this stark sentence: “Spanish doctors in Barcelona believe they've found the cure to HIV.” The fact that the procedure itself is associated with a 15–25 percent risk of mortality is never mentioned, and its limitation to people with life-threatening cancers is referenced only in the last paragraph of the piece. Even then it states that the procedure is “primarily designed to assist HIV patients suffering from cancer,” when the reality is that it can only be tried in individuals requiring stem cell transplants for cancers. A subsequent piece in El País does far better and contains a clear and accurate description of the research project, although it also contains a quote from Duarte that HIV was “eliminated” from the individual in Barcelona and the evidence does not appear sufficient to support this claim.

Update July 27, 2015: Strangely, the inaccurate and misleading Latino Post story has suddenly reappeared in mid-2015 on Africa-based news sites, in a slightly altered form with an even more horrendously false headline: "HIV Breakthrough! Spain Finds Functional Cure For HIV Virus (Confirmed)." As far as I can tell this version first appeared on the site News 24 Zimbabwe on June 24, but has more recently been added to In South Africa Today. Unfortunately, these inaccurate articles are now being widely circulated on social media. 

As mentioned in a prior posting, there are two research projects ongoing in the U.S. that are seeking to identify donors homozygous for the CCR5Δ32 mutation for HIV-positive people requiring stem cell transplants for cancers. One is for individuals 15 years or older and involves adult stem cells; the other is for both children and adults and will employ cord blood stem cells.

The company StemCyte has for some time been developing a bank of cord blood stem cells from donors homozygous for the CCR5Δ32 mutation and can make them available in individual cases (it supplied the cells for the man in Barcelona). Last year it provided cells for an HIV-positive boy with cancer in Minnesota, but he died due to graft-versus-host disease shortly after the transplant.

Lawrence Petz, the Medical Director of StemCyte, describes the company’s work in a recently published open-access review:

Cure of HIV-Infected Leukemia Patients with Cord Blood TransplantationJ Leuk 2014, 2:3 

November 2014

Story: French Scientists Find Mechanism for Spontaneous HIV Cure

Examples of media coverage: 

  1. French Scientists Find Mechanism for Spontaneous HIV Cure
 – Agence France-Presse, November 4, 2014
  2. Scientists See Mechanism for Spontaneous HIV “Cure” (Update) –
 Agence France-Presse, November 4, 2014
  3. HIV: Genetic Mutation Leads to Two Men Being “Spontaneously Cured” of Virus
 – International Business Times, November 4, 2014
  4. So-Called HIV ‘Cure’ Is Not Actually a Cure – Newsweek, November 5, 2014

Original source:

  1. Scientific journal article: HIV Infection en Route to Endogenization: Two CasesClinical Microbiology and Infection, November 4, 2014

TAG's commentary: Agence France-Presse launched this story onto the Internet on November 4, and it is being reposted and picked up by an increasing number of other outlets. The story relates to a scientific paper published on the same day in a little-known journal called Clinical Microbiology and Infection. The paper, authored by a group of French scientists (one of whom, Didier Raoult, is also the editor of the journal), describes two individuals who are reported to be HIV-positive but show no detectable HIV genetic material (RNA and DNA) in their blood by "standard methods." However, the lower limit of detection for the tests used is not stated. The individuals were identified from a cohort of elite controllers, who frequently have HIV RNA levels below the limit of detection of standard viral load tests (less than 400 copies or less than 50 copies depending on the test). No testing using more recently developed ultrasensitive HIV RNA assays is reported. One of the individuals was diagnosed HIV-positive in 1985; the other was diagnosed in 2011 and is thought to have been infected for a shorter period of around 3–6 years. The researchers used "deep sequencing" techniques to find and analyze HIV DNA in blood samples from the two cases, and report that the viral DNA they found showed a significant number of mutations, which they conclude have inactivated the virus. Based on this preliminary finding, derived only from analysis of peripheral blood and not the lymphoid tissues, where the majority of HIV is known to reside, the researchers claim that both individuals are cured. In one case, CD4 T-cell and CD8 T-cell count data are presented and are normal, whereas in the other no information on these measurements is provided. 

From TAG's perspective, the data are not sufficient to justify the claim that these two cases represent cures of HIV infection and not examples of elite control. The hypermutation of HIV in elite controllers has been reported previously, although it is not a universal finding

The authors of the paper propose an improbable-sounding theory to account for their claims, which is that HIV has become endogenous in some people, which would mean that HIV had managed to integrate into either a sperm or egg cell and then transferred to the offspring of the person in whom this integration took place. Currently, there is absolutely no evidence that this has ever happened with HIV. There are remnants of other ancient retroviruses in the human genome that have undergone this process sometime in the distant past (these are referred to as endogenous retroviruses), but no one has presented evidence that HIV has become endogenous in anybody (it would cause HIV genes to be present in every DNA-containing cell in the body). The authors also propose that the mutations they found in the HIV sequences identified in these two individuals were caused by a human enzyme, APOBEC 3G; this seems less unreasonable because the mutation-inducing activity of APOBEC 3G has been described by many scientists, and, as mentioned above, hypermutation of HIV has been reported in some elite controllers. 

In sum, it is possible that something of value for HIV cure research may be learned from these cases, but a lot more information is needed. In the absence of additional information, the statement in some of the headlines that these scientists have found a mechanism for a spontaneous HIV cure is erroneous. To its great credit, Agence France-Presse has produced an update to its original story, which includes several skeptical quotes about the paper from independent scientists. Also, on November 5th, Newsweek published an article disputing the claims made in the paper, noting that the evidence presented is consistent with the two individuals being elite controllers (not cases of HIV cures). 

July 2014

Story: Gene Editing Technique Removes HIV from Infected Cells

Examples of media coverage: 

  1. Researchers Find New Way to Kick Out HIV from Infected Cells – Time, July 21, 2014
  2. Temple Researchers Snip Out Dormant HIV from Cells – Philadelphia Enquirer, July 22, 2014
  3. Genome Editing Cuts Out HIV – Scientist, July 21, 2014

Original sources:

  1. Scientific journal article: RNA-Directed Gene Editing Specifically Eradicates Latent and Prevents New HIV-1 InfectionPNAS, July 21, 2014
  2. Press release: Temple University Researchers Eliminate the HIV Virus from Cultured Human Cells for First Time – Temple University Health System, July 21, 2014

TAG's commentary: This story originates from a study published in the scientific journal PNAS on July 21, 2014. The study employed a relatively new technology designed to be able to delete specific genes from the human genome (often likened to scissors snipping out the targeted genes). The researchers assessed whether the approach could delete HIV that had integrated into the genome of infected cells. The integration of HIV into the genome of infected cells allows the virus to persist, and is the major obstacle to curing HIV infection. 

Importantly, the study was performed only in cells in a laboratory dish. No tests have been conducted yet in animals, and there is a long way to go before they might be performed in humans.

Contrary to the impression given by some of the media reports, the approach achieved varying degrees of success in the laboratory dish experiments. In the case of HIV-infected T cells, the technique appeared to reduce the proportion containing integrated HIV by about 50 percent. The Philadelphia Enquirer story picked up on this detail, noting: “the scissors did not work on every cell.” When the researchers assessed the effects of equipping cells with the gene-editing tool prior to exposing them to HIV, there was evidence of complete protection against infection by some HIV variants, whereas other HIV variants showed reduced levels but were still able to infect some of the cells.

There are a number of important challenges that need to be addressed in order to make this type of approach suitable for testing in people:

  • Safety: The major concern with gene-editing technologies is the potential for “off-target” effects—damage to genes that were not the intended targets. Unwanted damage to human genes could cause serious harm. Although no evidence of off-target effects was uncovered in the laboratory-dish experiments, further research, including animal-model studies, will be necessary to evaluate safety.
  • Activity: As noted above, the approach wasn’t always successful at editing out HIV from infected cells, or at protecting uninfected cells. The researchers also point out that the genetic variability of HIV poses a challenge, because the gene-editing technology targets specific HIV genetic sequences that may not be the same in all the viruses circulating globally, or even all the viruses present in an HIV-positive individual. 
  • Delivery: As highlighted in the story in the Scientist, an overarching challenge with this type of technology is figuring out how to safely deliver it to all the cells in which it would be needed. Latently infected cells containing integrated HIV are extremely rare in HIV-positive people on effective antiretroviral therapy, and so far no marker has been identified that would allow these cells to be specifically targeted by a delivery method. In the absence of such a marker, the daunting task would be to try to deliver the gene-editing technology into every cell in the body that might be susceptible to HIV infection. A related concern is that the gene-editing tool used in this study is a bacterial enzyme (named CRISPR-Cas9) which would be recognized as foreign by the human immune system. 


The idea of trying to snip integrated HIV DNA out of the genome of infected cells is not new; among the first to publicly propose it was a company called Cellectis in 2008. Last year, a German research group published a study in HIV-infected humanized mice using a similar idea, but with a different type of “scissor” technology that becomes active only in infected cells in which an HIV protein (Tat) is present (this likely prevents the approach from working in latently infected cells, due to the absence of the HIV Tat protein).

More broadly, there is widespread scientific interest in the potential of gene-editing technologies to correct genetic disorders. The high level of interest has already spurred scientific advances in recent years and there is reason to be optimistic that further improvements in gene-editing technologies can be achieved.

There are ongoing human clinical trials of a gene-editing-based candidate developed by Sangamo BioSciences named SB-728-T that does not target HIV, but instead modifies CD4 T cells with the aim of removing the CCR5 coreceptor (see the “Research Toward a Cure and Immune-Based and Gene Therapies” chapter of TAG’s 2014 Pipeline Report for additional information). The reason why this approach is further advanced is that the gene editing is done in the laboratory. The CD4 T cells are extracted from each trial participant, modified in the laboratory, and then expanded in number and reinfused (avoiding the need to deliver the gene-editing technology into the body).

For a recent, technical scientific review of gene-editing technologies in HIV research, see:

Newer Gene Editing Technologies toward HIV Gene Therapy – N. Manjunath, Guohua Yi, Ying Dang, and Premlata Shankar, Viruses, November 14, 2013

Story: Stem Cell Transplants for Cancers “Cleared” HIV in Two Australians

Examples of media coverage: 

  1. HIV “Cleared” in Two Australian Men after Bone-Marrow Transplants –  Sydney Morning Herald, July 19, 2014
  2. HIV Said Cleared in Two Bone Marrow Transplant Patients – Bloomberg News, July 18, 2014
  3. Cancer Treatment Clears Two Australian Patients of HIV – Nature News, July 18, 2014

Original sources:

  1. Presentation at the International AIDS Society Towards an HIV Cure Symposium, Melbourne, Australia, July 19, 2014 (see abstract #PE48LB on page 74 of the symposium abstract book)
  2. Two Sydney Men Clear HIV after Bone Marrow Transplants – University of New South Wales press release, July 18, 2014

TAG's commentary: The headlines relating to this story are very misleading. There is no evidence as yet that HIV has been “cleared” from these two individuals, as both remain on ART. Rather, HIV is undetectable by a variety of tests. Most of the stories do mention this critical fact, even though the headlines are inaccurate. A news item in the scientific journal Nature, which might be expected to be more accurate than other media, erroneously describes the men as "apparently HIV-free." An article in the New Scientist also specifically addresses concerns about the misleading coverage:

Latest HIV “Cure” Claims Prompt Calls for More Caution – Andy Coghlan and Jessica Hamzelou, New Scientist, July 22, 2014

As this and several other articles point out, recent experience strongly cautions against assuming that the inability to detect HIV means that the virus is no longer present in the body.  A previously published report regarding two HIV-positive individuals in Boston who received stem cell transplants to treat cancers described an absence of detectable HIV. These cases received a lot of publicity in July of last year because HIV remained undetectable after ART was interrupted. However, in December, it was announced that viral load had rebounded in both individuals, after 12 weeks in one case and 32 weeks in the other. These results were published on July 22 in the journal Annals of Internal Medicine.


Stem cell transplantation is a high-risk procedure used to treat certain serious cancers. There is significant interest in studying people with HIV who undergo stem cell transplants to treat cancers because of evidence that the procedure contributed to eliminating HIV in Timothy Brown, the only person considered cured of HIV infection. However, Brown received stem cells from a donor with a genetic mutation known as CCR5Δ32, which renders cells resistant to most HIV strains. The Boston patients did not receive stem cells from donors with this mutation.

Of the two Australian cases, one received stem cells from a donor heterozygous for the CCR5Δ32 mutation (they inherited the mutation from one parent, not both), meaning their cells are less susceptible to HIV, but not resistant. The other received stem cells from a normal donor. Conducting an ART interruption is the only way for researchers to assess whether these individuals will maintain undetectable levels of HIV in the absence of ongoing treatment.

A number of research studies are looking into the effects of stem cell transplantation in HIV-positive people who require the procedure as part of treatment for cancer. Two trials in the United States are attempting to find compatible stem cell donors homozygous for the CCR5Δ32 mutation in order to try to repeat the cure achieved in Timothy Brown.

In Europe, the European HIV Cure and Transplant Consortium (EHCTC) is also aiming to try to identify stem cell donors homozygous for the CCR5Δ32 mutation for HIV-positive people requiring stem cell transplants to treat cancers.