A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online registry. Click the trial registry identifier numbers for a link to the full entry containing detailed information on the trial design, enrollment criteria, principal investigators and location(s). It’s important to appreciate that at the current time, none of these studies is expected to produce a cure for HIV infection—they represent research working toward that goal.
Entries shaded in light grey include analytical treatment interruptions (ATIs); in some cases the ATIs are only initiated if certain outcomes are achieved. Table 3 contains completed studies, with links to published or presented results where available. Changes from the previous update are highlighted in yellow. Additional information on current approaches in HIV cure research can be found in TAG’s annual pipeline report. Please send updates, corrections, or suggestions to Richard Jefferys at richard.jefferys@treatmentactiongroup.org.
COVID-19 Update, 8/16/21: The clinical research featured in this listing has been significantly affected by the COVID-19 pandemic. Trials that have yet to begin recruiting may be delayed, and there have been temporary suspensions of enrollment for some ongoing studies. Research is restarting as the situation improves in some areas, but study contacts listed in the individual trial registry entries should be contacted for the latest information. The International AIDS Society (IAS) has issued guidance on mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.
May 16, 2022
Table 1. Current Clinical Trials
|
Trial |
Trial Registry Identifier(s) |
Sponsor(s) |
Phase |
Estimated End Date/Interim |
|
ADOPTIVE IMMUNOTHERAPY |
||||
|
AutoRESIST: HIV antigen-specific T-cells targeting conserved epitopes for treatment of HIV-associated |
Catherine Bollard, Children’s |
Phase II |
June 2026 |
|
|
AlloRESIST: Evaluate the safety, immunologic, and virologic responses of donor derived |
Catherine Bollard, Children’s |
Phase I |
April 2024 |
|
|
HST-NEETs: HIV-1 specific T-cells for HIV+ individuals |
NCT03485963 |
Children’s Research Institute |
Phase I |
December 2023 |
|
ANTIBODIES |
||||
|
VRC01 (analytical treatment interruption in HVTN 703/HPTN 081 AMP trial participants) |
HIV Vaccine Trials Network |
N/A |
November 2022 |
|
|
VRC01 (analytical treatment interruption in AMP trial participants) |
HIV Vaccine Trials Network |
N/A |
June 2023 |
|
|
GSK3810109A (broadly neutralizing |
ViiV Healthcare |
Phase IIa |
November 2023 |
|
|
10-1074-LS + 3BNC117-LS in primary HIV infection |
Imperial College London |
Phase II |
March 2025 |
|
|
3BNC117-LS + 10-1074-LS |
NCT05300035 |
French National Agency for |
Phase II |
February 2028 |
|
UB-421 (antibody inhibitor of HIV binding to CD4 receptors) |
NCT04404049 |
UBP Greater China (Shanghai) Co., Ltd |
Phase II |
June 2024 |
|
vedolizumab (anti-α₄β₇ integrin |
Ottawa Hospital Research |
Phase II |
December 2021 |
|
|
ABBV-382 (anti-α₄β₇ integrin antibody) |
AbbVie |
Phase Ib |
June 2023 |
|
|
3BNC117-LS +10-1074-LS |
NCT05079451 |
NIAID |
Phase I |
February 2024 |
|
AAV8-VRC07 (broadly neutralizing antibody delivered by AAV vector) |
NCT03374202 |
NIAID
|
Phase I |
March 2027 CROI 2022, Abstract 498 |
|
SAR441236 (tri-specific broadly neutralizing antibody) |
NIAID |
Phase I |
November 2022 |
|
|
ANTI-CMV THERAPY |
||||
|
letermovir (Prevymis) |
NCT04840199 |
NIAID |
Phase II |
June 2024 |
|
ANTI-INFLAMMATORY |
||||
|
canakinumab (IL-1β inhibitor) |
NCT02272946 |
University of California, San Francisco |
Phase II |
December 2022 |
|
Camu Camu (Myrciaria dubia) |
McGill University Health Centre |
Phase I |
December 2022 |
|
|
ANTIRETROVIRAL THERAPY |
||||
|
IDOLTIB: Impact of dolutegravir + lamivudine simplification on HIV-1 reservoirs |
NCT04034862 |
University of Liege |
Phase III |
June 2023 |
|
CANNABINOIDS |
||||
|
GALIG-CBD: Effects of cannabidiol on the activation of autophagy and inflammation genes, functional consequences in virologically controlled HIV+ patients |
NCT05306249 |
Centre Hospitalier Régional d’Orléans |
Phase II |
December 2022 |
|
TN-CT11LM, TN-TC19LM oral capsules |
NCT03550352 |
McGill University Health Center |
Phase II |
August 2022 |
|
COMBINATIONS |
||||
|
Perturbing of HIV reservoir with immune stimulation: Fluarix, |
NCT02707692 |
University of California, San Diego |
Not listed |
January 2022 |
|
MVA.HTI + ChAdOx1.HTI therapeutic vaccines + vesatolimod (TLR7 agonist) |
NCT04364035 |
Aelix Therapeutics |
Phase IIa |
December 2022 |
|
TITAN: lefitolimod + 3BNC117 + 10-1074 (TLR9 agonist + broadly neutralizing antibodies) |
NCT03837756 |
University of Aarhus |
Phase IIa |
February 2023 |
|
VRC07-523LS, CAP256V2LS, vesatolimod |
NCT05281510 |
Gilead Sciences |
Phase IIa |
February 2024 |
|
Albuvirtide (fusion |
NCT04819347 |
Frontier Biotechnologies Inc. |
Phase II |
December 2022 |
|
ASC22 (anti-PD-L1 antibody) + chidamide (HDAC inhibitor) |
NCT05129189 |
Shanghai Public Health Clinical Center |
Phase II |
May 2023 |
|
MVA HIV-B +/- vedolizumab |
NCT04120415 |
ANRS |
Phase II |
December 2022 |
|
Research in Viral Eradication of HIV Reservoirs (RIVER): |
NCT02336074 |
Imperial College London
|
Phase II |
November 2022 |
|
UB-421 + chidamide (antibody inhibitor of HIV binding to CD4 receptors + HDAC |
NCT04985890 |
UBP Greater China (Shanghai) Co., |
Phase II |
December 2025 |
|
UB-421 + chidamide |
United BioPharma |
Phase II |
December 2023 |
|
|
vorinostat +/- tamoxifen |
NCT03382834 |
NIAID |
Phase II |
June 2023 |
|
Ad26.Mos4.HIV, MVA-BN-HIV, |
Boris Juelg, MD PhD |
Phase I/IIa |
March 2024 |
|
|
HIVARNA01.3, MVA |
NCT03619278 |
David Garcia Cinca |
Phase I/IIa |
July 2021 |
|
IMPAACT P1115 v2.0: Very |
IMPAACT |
Phase I/II |
December 2031 |
|
|
panobinostat + pegylated |
Massachusetts General Hospital |
Phase I/II |
December 2021 |
|
|
Therapeutic conserved element DNA vaccine (IL-12 adjuvanted p24CE), MVA vaccine boost (MVA/HIV62B), TLR9 |
NCT04357821 |
UCSF |
Phase I/II |
December 2024 |
|
elipovimab (formerly |
GS-US-420-3902 (no clinicaltrials.gov entry) |
Gilead Sciences |
Phase Ib |
N/A |
|
CD4-ZETA gene–modified T |
NCT01013415 |
University of Pennsylvania |
Phase I |
March 2022 |
|
HVRRICANE: HIVIS |
PENTA Foundation |
Phase I |
October 2023 |
|
|
N-803 (recombinant human super agonist interleukin-15 complex) +/- VRC07-523LS |
NIAID |
Phase I |
November 2024 |
|
|
N-803, 3BNC117-LS, 10-1074-LS |
NCT05245292 |
Rockefeller University |
Phase I |
September 2025 |
|
peginterferon alfa-2b + 3BNC117 + 10-1074 (BEAT-2) |
NCT03588715 |
Wistar Institute |
Phase I |
October 2022 |
|
vorinostat + HXTC: HIV 1 |
NCT03212989 |
Julia Sung, MD, University of North Carolina, |
Phase I |
June 2022 |
|
CYTOKINES |
||||
|
N-803 in acute HIV infection |
Thai Red Cross AIDS Research Centre |
Phase II |
August 2022 |
|
|
Effect of N-803 on B cell follicles |
University of Minnesota |
Phase I |
February 2023 |
|
|
DUAL-AFFINITY RE-TARGETING (DART) MOLECULES |
||||
|
MGD020 +/- MGD014 |
NCT05261191 |
MacroGenics |
Phase I |
July 2023 |
|
GENE THERAPIES |
||||
|
EBT-101 (CRISPR/Cas9 |
Excision BioTherapeutics |
Phase I/IIa |
March 2025 |
|
|
LVgp120duoCAR-T cells |
Steven Deeks, UCSF |
Phase I/IIa |
December 2024 |
|
|
Cal-1: Dual anti-HIV gene transfer construct |
NCT02390297 |
Calimmune |
Phase I/II |
October 2031 |
|
SB-728-T (autologous T cells gene-modified to disrupt CCR5 receptor expression) |
NCT03666871 |
Case Western Reserve University |
Phase I/II |
February 2024 |
|
AGT103-T (gene-modified HIV-specific CD4 T cells) |
American Gene Technologies International Inc. |
Phase I |
September 2022 |
|
|
CD4 CAR + SB-728mR modified |
NCT03617198 |
University of Pennsylvania |
Phase I |
December 2025 |
|
Chimeric Antigen Receptor (CAR)-T |
Guangzhou 8th People’s Hospital |
Phase I |
December 2022 |
|
|
EBT-101 (long-term follow-up study) |
NCT05143307 |
Excision BioTherapeutics |
Phase I |
April 2037 |
|
Long-term follow-up of HIV+ participants exposed to SB-728-T or SB-728mR-T |
NCT04201782 |
Sangamo Therapeutics |
Phase I |
December 2033 |
|
SB-728mR-HSPC (autologous |
NCT02500849 |
City of Hope Medical Center |
Phase I |
December 2023 |
|
TCTIWHI: Third-generation CAR-T-cell therapy |
NCT04863066 |
Beijing 302 Hospital |
Phase I |
October 2022 |
|
GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS |
||||
|
Stem cells gene-modified with Cal-1 |
Assistance Publique – Hôpitaux de |
Phase I/II |
January 2024 |
|
|
Stem cells gene-modified with CCR5 |
AIDS Malignancy Consortium |
Phase I/II |
September 2024 |
|
|
Stem cells gene-modified to |
NCT02337985 |
City of Hope Medical Center |
Phase I |
December 2022 |
|
Stem cells gene-modified to |
NCT01961063 |
City of Hope Medical Center |
Phase I |
December 2022 |
|
GONADOTROPIN-RELEASING HORMONE (GnRH) AGONISTS |
||||
|
triptorelin acetate depot |
Immune System Regulation AB |
Phase II |
December 2021 |
|
|
IMAGING STUDIES |
||||
|
Imaging immune activation in HIV by PET-MR |
University of California, San Francisco |
Phase I |
October 2024 |
|
|
Radiolabeled VRC01 |
University of California, San Francisco |
Phase I |
October 2021 |
|
|
IMMUNE CHECKPOINT INHIBITORS |
||||
|
ASC22 (anti-PD-L1 |
NCT05330143 |
Ascletis Pharmaceuticals |
Phase II |
March 2023 |
|
budigalimab (anti-PD-1 |
AbbVie |
Phase Ib |
February 2023 |
|
|
budigalimab (anti-PD-1 antibody) |
NCT04799353 |
AbbVie |
Phase I |
October 2022 |
|
NIVO-LD: Low dose nivolumab in |
NCT05187429 |
University of Melbourne |
Phase I/II |
January 2024 |
|
nivolumab (anti-PD-1 antibody) + |
|
National Cancer Institute (NCI) |
Phase I |
July 2022 |
|
pembrolizumab (anti-PD-1 antibody) in treating patients with HIV and relapsed, refractory, or disseminated |
National Cancer Institute (NCI) |
Phase I |
November |
|
|
pembrolizumab (anti-PD-1 antibody) single dose |
National Institute of Neurological Disorders |
Phase I |
December 2024 |
|
|
LATENCY-REVERSING AGENTS |
||||
|
arsenic trioxide |
Guangzhou 8th People’s Hospital |
Phase I |
December 2022 |
|
|
decitabine, romidepsin |
NCT05230368 |
ANRS |
Phase I |
April 2026 |
|
Euphorbia kansui |
NCT04503928 |
Shanghai Public Health Clinical Center |
Phase I |
December 2022 |
|
Kansui (traditional Chinese medicine containing ingenols) |
NCT02531295 |
UCSF |
Phase I |
June 2023 |
|
mTOR INHIBITORS |
||||
|
metformin |
University of Hawaii |
Phase II/III |
December 2022 |
|
|
STEM CELL TRANSPLANTATION |
||||
|
IMPAACT P1107: Cord blood |
(closed to enrollment) |
International Maternal Pediatric Adolescent |
N/A |
April 2022 |
|
Cord blood transplant with OTS for the treatment of HIV+ hematologic cancers |
Fred Hutchinson Cancer Research Center |
Phase II |
December 2025 |
|
|
STIMULANTS |
||||
|
EMRLHD: Effect of methamphetamine on residual |
University of California, San Francisco |
Phase IV |
June 2023 |
|
|
THERAPEUTIC VACCINES |
||||
|
BELIEVE: BCG |
University of Zurich |
Phase IIa |
January 2024 |
|
|
ChAdOx1.HTI, |
NCT05208125 |
IrsiCaixa |
Phase I |
May 2023 |
|
DC-HIV04: a1DC + |
Sharon Riddler, University of Pittsburgh |
Phase I |
May 2023 |
|
|
MVA.tHIVconsv3 |
NCT03844386 |
University of North Carolina, Chapel Hill |
Phase I |
June 2022 |
|
NETI: |
Madhuchhanda Choudhary |
Phase I |
January 2025 |
|
|
TREATMENT INTENSIFICATION/EARLY TREATMENT |
||||
|
Antiretroviral regime for viral eradication in newborns |
NCT02712801 |
National Center for Women and Children’s |
Phase IV |
December 2022 |
|
DGVTAF: Immediate initiation of antiretroviral therapy during “hyperacute” HIV infection |
NCT02656511 |
UCSF |
Phase IV |
April 2023 |
|
AAHIV: Antiretroviral |
South East Asia Research Collaboration with |
Phase III |
June 2033 |
|
|
EIT: Early infant HIV treatment in Botswana |
NCT02369406 |
Harvard School of Public Health |
Phase II/III |
May 2022 |
|
EARLIER: Early ART to limit infection and establishment of reservoir |
NCT02859558 |
AIDS Clinical Trials Group |
Phase II |
September 2023 |
|
EDIT: Effect |
University of Liege |
Phase II |
October 2022 |
|
Table 2. Current Observational Studies
|
Trial |
Trial Registry Identifier(s) |
Manufacturer/ |
Phase |
Estimated End Date/Interim |
|
2000HIV: 2000 HIV human functional genomics partnership |
NCT03994835 |
Radboud University |
N/A |
December 2023 |
|
2000HIVTrained: 2000 HIV trained |
NCT04968717 |
Radboud University |
N/A |
December 2022 |
|
Accurate staging of immuno-virological |
University Hospital, Ghent |
N/A |
January 2023 |
|
|
Analytic treatment interruption |
NCT02437526 |
Mayo Clinic |
N/A |
|
|
ANRS CO24 OncoVIHAC: Immune checkpoint |
Inserm-ANRS |
N/A |
June 2022 |
|
|
ATGALIG-HIV: Study of autophagy and the effects |
Centre Hospitalier Régional d’Orléans |
N/A |
November 2029 |
|
|
BICTEVOIR: A study to determine the cartography |
NCT05222945
|
ANRS
|
N/A |
March 2024 |
|
CHRONO: A prospective cohort for ex vivo cure |
Erasmus Medical Center |
N/A |
January 2034 |
|
|
CODEX (the “Extreme” cohort, ANRS CO21) |
Inserm-ANRS |
N/A |
September 2023 |
|
|
Developing a functional cure for HIV disease: |
American Gene Technologies International Inc. |
N/A |
February 2021 |
|
|
DOLUVOIR: Cartography of virologic reservoir |
Inserm-ANRS |
N/A |
November 2023 |
|
|
Establish and characterize an acute HIV |
Southeast Asia Research Collaboration with |
N/A |
July 2033 |
|
|
Evaluation of the role of HIV-1 Tat protein |
Barbara Ensoli, MD, PhD, Istituto Superiore |
N/A |
December 2023 |
|
|
Expectation, motivation and experience of |
NCT05280392 |
ANRS |
N/A |
March 2025 |
|
EX VIVO: Ex vivo characterization and |
Erasmus Medical Center |
N/A |
December 2030 |
|
|
FRESH (Females rising through education, support, |
Ragon Institute |
Ragon Institute of MGH, MIT and Harvard |
N/A
|
|
|
FXR#2: Selection of farnesoid X receptor (FXR) |
NCT05219916 |
Hospices Civils de Lyon |
N/A |
September 2024 |
|
HEATHER: HIV reservoir targeting with early |
UK CPMS17589 |
University of Oxford/Medical Research |
N/A |
September 2019 Front Immunol. 2021; |
|
HIV-Mercuri: HIV study on measuring the reservoir |
University Hospital, Ghent |
N/A |
December 2025 |
|
|
Host & viral factors associated with HIV |
UK CPMS16146 |
University College London Hospitals NHS |
N/A |
May 2021 |
|
HUSH restriction in HIV+ patients |
Inserm-ANRS |
N/A |
September 2023 |
|
|
iCHIP: Effect of immune checkpoint inhibitors on |
hivcure.com.au (no registry entry) |
University of Melbourne |
N/A |
N/A |
|
IciStem: |
IciStem website (no clinicaltrials.gov |
amfAR |
N/A |
N/A CROI 2020, Abstract 339 |
|
Identification and quantification of HIV CNS |
St Vincent’s Hospital, Sydney
|
N/A |
December 2020 |
|
|
Investigation of the impact of inducible, |
Kenya Medical Research Institute |
N/A |
April 2022 |
|
|
LAMIVIH: Evolution of HIV reservoir, |
NCT05303337 |
Hôpital Européen Marseille |
N/A |
March 2024 |
|
Long-term clinical, immunologic, and |
IMPAACT |
N/A |
November 2027 |
|
|
Long-term effects of ART in acute HIV |
Key Laboratory of AIDS Immunology of National |
N/A |
June 2021 |
|
|
Measurement for viral reservoir and immune |
National Taiwan University Hospital |
N/A |
December 2021 |
|
|
Post analytic treatment interruption study |
South East Asia Research Collaboration with |
N/A |
March 2031 |
|
|
PRIMO (ANRS CO6): Primary infection cohort |
Inserm-ANRS |
N/A |
December 2022 |
|
|
RESERVIH32: Bioclinical evaluation of two |
Centre Hospitalier Universitaire de Nīmes |
N/A |
September 2022 |
|
|
Role of the IL-33/amphiregulin pathway as a |
Inserm-ANRS |
N/A |
September 2023 |
|
|
Saturne-HIV: Sequential analysis before and after |
University Hospital, Ghent |
N/A |
January 2025 |
|
|
SCOPE-ATI: SCOPE analytic treatment interruption protocol |
UCSF |
N/A |
June 2024 |
|
|
TESOVIR: |
Centre Hospitalier Régional |
N/A |
September 2022 |
|
|
The Gemini Study: Safety and survival of |
NCT04799483 |
NIAID |
N/A |
January 2030 |
|
The Last Gift Study (for people with HIV and |
University of California, San Diego (UCSD) |
N/A |
N/A |
|
|
The use of leukapheresis to support HIV |
University of California, San Francisco |
N/A |
December 2022 |
|
|
Thinking and memory problems in people with |
National Institute of Neurological Disorders |
N/A |
February 2037 |
|
|
TRESAX: T follicular helper reservoir in axillary |
hivcure.com.au (no registry entry) |
Kirby Institute |
N/A |
N/A |
Table 3. Completed Studies
|
Trial |
Trial Registry Identifier(s) |
Manufacturer/ |
Phase |
Published/Presented Data |
|
ADOPTIVE IMMUNOTHERAPY |
||||
|
Early ART in combination with |
Yongtao Sun, MD, PhD, Tangdu |
Phase III |
N/A |
|
|
Reconstitution of HIV-specific |
Guangzhou 8th People’s Hospital |
Phase I/II |
N/A |
|
|
HIV-specific memory CD8 T cells |
Beijing You’an Hospital, Capital |
Phase I |
||
|
HXTC: HIV 1 |
University of North Carolina, |
Phase I |
||
|
ANTIBODIES |
||||
|
3BNC117 (broadly neutralizing monoclonal |
Rockefeller University |
Phase II |
||
|
3BNC117 |
Rockefeller University |
Phase II |
N/A |
|
|
UB-421 (antibody |
United BioPharma |
Phase II |
N/A |
|
|
UB-421 |
United BioPharma |
Phase II |
||
|
vedolizumab (anti-α₄β₇ |
Hospitales Universitarios Virgen del Rocío |
Phase II |
||
|
VRC01 (broadly neutralizing monoclonal antibody) |
National Institute of Allergy and Infectious |
Phase II |
J Clin Invest. 2020 |
|
|
PGT121 + VRC07-523LS +/- PGDM1400 (broadly neutralizing antibodies) |
International |
Phase I/IIa |
N/A |
|
|
VRC01 (broadly neutralizing antibody) in |
NIAID |
Phase I/II |
N/A |
|
|
VRC01LS + 10-1074 (broadly |
NIAID |
Phase I/II |
CROI 2022, Abstract 32 |
|
|
10-1074 (broadly neutralizing monoclonal |
Rockefeller University |
Phase I |
||
|
10-1074-LS + 3BNC117-LS (long-acting broadly neutralizing |
Rockefeller University |
Phase I |
N/A |
|
|
3BNC117 |
Rockefeller University |
Phase I |
||
|
3BNC117 + 10-1074 |
NIAID |
Phase I |
N/A |
|
|
3BNC117 + 10-1074 |
Rockefeller University |
Phase I |
||
|
3BNC117 + 10-1074 |
Rockefeller University |
Phase I |
Nature. 2022 Apr 13 |
|
|
3BNC117-LS + 10-1074-LS in viremic HIV+ |
Rockefeller University |
Phase I |
CROI 2022, Abstract 140 |
|
|
3BNC117-LS |
Rockefeller University |
Phase I |
N/A |
|
|
CHERUB 001 |
No clinicaltrials.gov entry |
CHERUB (Collaborative HIV Eradication of |
N/A |
|
|
elipovimab (formerly GS-9722; PGT121-derived |
GS-US-420-3902 Adisinsight entry |
Gilead Sciences |
Phase I |
CROI 2020, Abstract 39, Webcast |
|
PGDM1400 +/– PGT121 +/– VRC07-523LS (broadly |
International AIDS Vaccine Initiative |
Phase I |
Nat Med. 2022 May |
|
|
PGT121 |
International AIDS Vaccine Initiative |
Phase I |
Nat Med. 2021 Oct 7. |
|
|
vedolizumab |
NIAID |
Phase I |
AIDS 2018, WESS0102 |
|
|
VRC01 + 10-1074 |
NIAID |
Phase I |
N/A |
|
|
VRC01 in acute HIV infection |
NIAID |
Phase I |
N/A |
|
|
VRC01 |
NIAID |
Phase I |
N/A |
|
|
VRC01 |
NIAID |
Phase I |
||
|
VRC01 |
NIAID |
Phase I |
N Engl J Med. 2016 |
|
|
VRC01 |
NIAID |
Phase I |
||
|
VRC01LS, VRC07-523LS (long-acting broadly neutralizing |
NIAID |
Phase I |
IAS 2019, Abstract WEAA0305LB (video, at 45:36) |
|
|
ANTI-FIBROTIC |
||||
|
ACE inhibitors |
UCSF/amfAR |
Phase IV |
||
|
losartan |
University of Minnesota |
Phase II |
CROI 2020, Abstract 277 |
|
|
telmisartan |
AIDS Clinical Trials Group |
Phase II |
CROI 2019, Abstract 395 |
|
|
telmisartan |
Yale University |
Phase I |
CROI 2019, Abstract 300 |
|
|
ANTI-INFLAMMATORY |
||||
|
CD24Fc (human CD24 extracellular domain and human |
OncoImmune, Inc. |
Phase II |
“Terminated (Business Reasons)” |
|
|
High dose vitamin D supplementation |
University of Melbourne |
Phase II |
CROI 2022, Abstract 355 |
|
|
CC-11050 (phosphodiesterase-4 inhibitor) |
NIAID |
Phase I |
Open Forum |
|
|
ANTI-PROLIFERATIVE |
||||
|
mycophenolate mofetil (MMF) |
Fred Hutchinson Cancer Research Ctr |
Phase I |
CROI 2020, Abstract 340 |
|
|
ANTIRETROVIRAL THERAPY |
||||
|
dolutegravir in reservoirs |
Emory University |
Phase IV |
||
|
HIV reservoir dynamics after switching to |
Hospital Universitari Vall d’Hebron Research |
Phase IV |
N/A |
|
|
raltegravir or efavirenz + tenofovir + emtricitibine |
University of Alabama at Birmingham |
Phase IV |
N/A |
|
|
doravirine concentrations and antiviral |
Fundacio Lluita Contra la SIDA |
Phase III |
||
|
ABX464 |
Abivax S.A. |
Phase II |
||
|
ABX464 |
Abivax S.A. |
Phase I/II
|
Clin Infect Dis. 2021 16th European Meeting on HIV & Hepatitis |
|
|
ANTIRETROVIRAL THERAPY IN HIV CONTROLLERS |
||||
|
emtricitabine + rilpivirine |
AIDS Clinical Trials Group/NIAID |
Phase IV |
J Infect Dis. 2020 |
|
|
raltegravir + tenofovir + emtricitabine |
University of California, San Francisco |
Phase IV |
||
|
ASSEMBLY INHIBITORS |
||||
|
BIT225 |
Biotron Limited |
Phase II |
J Infect Dis. 2021 |
|
|
BIT225 |
Biotron Limited |
Phase I |
||
|
COMBINATIONS |
||||
|
maraviroc, dolutegravir, |
Federal University of São Paulo |
Not listed |
CROI 2021, Abstract 313 |
|
|
ROADMAP: romidepsin |
Rockefeller University |
Phase IIa |
Lancet Microbe. 2022 |
|
|
Adoptive transfer of haploidentical |
University of Minnesota – Clinical and |
Phase II |
N/A |
|
|
eCLEAR: romidepsin + 3BNC117 |
NCT03041012 |
Aarhus University Hospital |
Phase II |
CROI 2022, Abstract 62, Abstract 122 |
|
ERAMUNE-01 |
ORVACS/Cytheris SA/Merck Sharp & Dohme |
Phase II |
||
|
ERAMUNE-02 (DNA/Ad5 vaccine, ART intensification) |
|
Vical/GenVec/CHERUB/NIH Vaccine Research |
Phase II |
Lancet HIV. 2015 CROI 2014, Poster abstract 422 |
|
disulfiram + vorinostat |
NCT03198559 |
The Peter Doherty Institute for Infection and |
Phase I/II |
AIDS. 2021 Sep 29. |
|
GTU-MultiHIV B-clade + MVA HIV-B +/- |
Inserm-ANRS |
Phase I/II |
Terminated due to the bankruptcy of FITBiotech |
|
|
Vacc-4x |
Bionor Immuno AS/Celgene |
Phase I/II
|
CROI 2019, Abstract 397 |
|
|
Vacc-4x |
Bionor Immuno AS |
Phase I/II |
IAS 2015 Towards an HIV Cure Symposium, Poster abstract PE61 |
|
|
vorinostat + hydroxychloroquine + maraviroc |
NCT02475915 |
South East Asia Research Collaboration with |
Phase I/II |
J Virus Erad. 2020 |
|
Adoptive transfer of haploidentical |
University of Minnesota – Clinical and |
Phase I |
N/A |
|
|
AGS-004 + vorinostat |
NIAID |
Phase I |
Sci Rep. 2020 Mar |
|
|
chemotherapy + |
Fundacion para la Investigacion Biomedica del |
Phase I |
Terminated due to futility criteria |
|
|
Chidamide + CAR-T |
Guangzhou 8th People’s Hospital |
Phase I |
N/A |
|
|
DCV3 |
Judit Pich Martínez, Fundació |
Phase I |
Front Immunol. 2021 |
|
|
MVA-B (viral |
Hospital Clinic of |
Phase I |
||
|
MVA.HIVconsv |
IrsiCaixa |
Phase I
|
Microbiome. 2022 Apr |
|
|
VRC07-523LS + vorinostat |
University of North Carolina, Chapel Hill |
Phase I |
J Infect Dis. 2021 |
|
|
CYTOKINES |
||||
|
interleukin-2 (IL-2) |
Case Western Reserve University |
Phase II |
N/A |
|
|
N-803 |
University of Minnesota – Clinical and |
Phase I |
Nat Med. 2022 Jan 31. |
|
|
DUAL-AFFINITY RE-TARGETING (DART) MOLECULES |
||||
|
MGD014 |
MacroGenics |
Phase I |
N/A |
|
|
GENE THERAPIES |
||||
|
OZ1 |
Janssen-Cilag Pty Ltd |
Phase II |
||
|
Cal-1: Dual anti-HIV gene transfer construct |
Calimmune |
Phase I/II |
||
|
SB-728mR-T (autologous CD4 T cells genetically |
Sangamo BioSciences |
Phase I/II |
N/A |
|
|
SB-728-T + |
Sangamo BioSciences |
Phase I/II
|
bioRxiv CROI 2015, Poster abstract 434 CROI 2014, Abstract 141, Webcast |
|
|
SB-728-T |
Sangamo BioSciences |
Phase I/II |
N/A |
|
|
VRX496 (gene-modified autologous CD4 T cells) |
University of Pennsylvania |
Phase I/II |
||
|
C34-CXCR4 (autologous CD4 T cells gene-modified |
University of Pennsylvania
|
Phase I |
N/A |
|
|
HGTV43 |
No clinicaltrials.gov entry |
Enzo Biochem |
Phase I |
AIDS 2006, Abstract MOPDA06 |
|
MazF-T (redirected MazF-CD4 autologous T cells) |
Takara Bio/University of Pennsylvania |
Phase I |
Mol Ther 2020 Nov 10 |
|
|
Redirected high affinity Gag-specific T cells |
University of Pennsylvania/Adaptimmune |
Phase I |
Study closed (safety): Mol Ther. 2015 Jul; |
|
|
SB-728mR-T + |
University of Pennsylvania |
Phase I |
J Clin Invest. 2021. |
|
|
SB-728-T |
Sangamo BioSciences |
Phase I |
bioRxiv |
|
|
SB-728-T
|
Sangamo Biosciences/University of |
Phase I |
||
|
shRNA-modified CD34+ cells |
Shanghai Public Health Clinical Center |
Phase I |
N/A |
|
|
GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS |
||||
|
CRISPR CCR5 modified CD34+ cells |
307 Hospital of PLA (Affiliated |
Not listed |
||
|
Stem cells gene-modified with M87o vector |
Universitätsklinikum Hamburg-Eppendorf |
Phase I/II |
N/A |
|
|
Stem cells gene-modified to encode multiple |
City of Hope Medical Center |
Phase I |
||
|
HORMONES |
||||
|
somatotropin (human growth hormone) |
McGill University Health Center |
Phase II |
CROI 2021, Abstract 298, Webcast |
|
|
IMAGING STUDIES |
||||
|
123I radiolabeled 3BNC117 |
University of Lausanne Hospitals |
Phase I |
N/A |
|
|
Radiolabeled 3BNC117 + Copper-64 radio |
Bayside Health |
Phase I |
EBioMedicine. 2021 |
|
|
IMMUNE CHECKPOINT INHIBITORS |
||||
|
durvalumab (anti-PD-L1 |
Spanish Lung Cancer Group |
Phase II |
ESMO 2020, Abstract |
|
|
cemiplimab (anti-PD-1 antibody) |
NIAID |
Phase I/II |
J Acquir Immune Defic |
|
|
BMS-936559 (anti-PD-L1 antibody) |
National Institute of Allergy and Infectious |
Phase I |
J Infect Dis. 2017 CROI 2016, Abstract 25, Webcast |
|
|
ipilimumab (anti-CTLA-4 antibody) |
Medarex |
Phase I |
||
|
IRON CHELATORS |
||||
|
deferiprone |
ApoPharma |
Phase I |
N/A |
|
|
JANUS KINASE INHIBITORS |
||||
|
ruxolitinib |
NIAID |
Phase II |
J Clin Pharmacol. |
|
|
LATENCY-REVERSING AGENTS |
||||
|
disulfiram |
University of California, San Francisco/ |
Not specified |
||
|
Chidamide |
Tang-Du Hospital |
Phase II/III |
N/A |
|
|
vorinostat (HDAC inhibitor) |
Bayside Health/Merck |
Phase II |
||
|
valproic acid (HDAC inhibitor) |
McGill University/Canadian Foundation for |
Phase II |
||
|
valproic acid |
University of North Carolina at Chapel |
Phase II
|
||
|
Chidamide (HDAC inhibitor) |
Tang-Du Hospital |
Phase I/II |
HIV Med. 2020 |
|
|
disulfiram (acetaldehyde dehydrogenase |
University of California, San |
Phase I/II |
CROI 2015, Poster abstract 428LB |
|
|
panobinostat (HDAC |
University of Aarhus/ |
Phase I/II |
CROI 2015, Abstract 109, Webcast |
|
|
romidepsin (HDAC inhibitor) |
AIDS Clinical Trials Group/NIAID/Gilead |
Phase I/II
|
The Journal of |
|
|
valproic acid + pyrimethamine |
Erasmus Medical Center |
Phase I/II |
N/A |
|
|
vorinostat |
University of North Carolina at Chapel |
Phase I/II |
J Clin Invest. 2017 Aug 1;127(8):3126-3135. |
|
|
bryostatin 1 (PKC agonist) |
Fundacion para la Investigacion Biomedica del |
Phase I |
||
|
mTOR INHIBITORS |
||||
|
Impact of Everolimus on HIV |
UCSF |
Phase IV |
||
|
Sirolimus |
ACTG |
Phase I/II |
CROI 2019, Abstract 131, Webcast |
|
|
metformin |
McGill University Health Center |
Phase I |
EBioMedicine 65 |
|
|
OBSERVATIONAL STUDIES |
||||
|
ACTG A5321: Decay of HIV-1 reservoirs in |
N/A |
AIDS Clinical Trials Group |
N/A
|
Front Cell Infect CROI 2018, Abstract 119, Webcast |
|
ANRS EP 44: Residual replication |
Inserm-ANRS |
N/A |
N/A |
|
|
ANRS EP63: A chronological study of the |
Inserm-ANRS |
N/A |
N/A |
|
|
APACHE: |
Ospedale San Raffaele |
N/A |
PLoS One. 2022 Mar J Antimicrob |
|
|
Biomarkers to predict time to |
AIDS Clinical Trials Group |
N/A |
AIDS Res Hum |
|
|
CHERUB 003 |
Imperial College London/CHERUB |
N/A |
N/A |
|
|
CLEAC: Comparison of late versus early |
Inserm-ANRS |
N/A |
Front Immunol. 2021 |
|
|
Effects of dolutegravir based regimen on |
University Hospital, Strasbourg, France |
N/A |
||
|
EPIC4: Early Pediatric Initiation: Canada Child |
Canadian Institutes of Health Research |
N/A
|
Clin Infect Dis. 2019 |
|
|
EURECA: Exploratory study of cellular reservoirs in |
Centre Hospitalier Universitaire de Besancon |
N/A |
||
|
FXReservoir: Study of the effects of farnesoid X |
Hospices Civils de Lyon |
N/A |
N/A |
|
|
Genotyping FcɣRs genes |
University Hospital, Strasbourg, France |
N/A |
||
|
HCURE: Impact of HCV DAAs on antiviral immunity |
Assistance Publique Hopitaux De Marseille |
N/A |
N/A |
|
|
HIV-PRADA: HIV persistence in lymph node and |
University of Melbourne |
N/A |
CROI 2021, Abstract 301, Webcast |
|
|
HIV resistance and treatment strategies |
NIAID |
N/A |
N/A |
|
|
HIV-STAR: HIV |
University Hospital, Ghent
|
N/A |
Cell |
|
|
HSCT-HIV: Allogeneic hematopoietic stem cell |
Kirby Institute |
N/A |
Terminated by Protocol Steering Committee |
|
|
ImmunoCo27: Co-adaptation between HIV and CD8 |
Inserm-ANRS |
N/A |
N/A |
|
|
IMPAACT 2015: Evaluation of the |
IMPAACT |
N/A |
N/A |
|
|
Impact of ART adherence on HIV persistence |
University of Colorado, Denver |
N/A |
N/A |
|
|
Impact of a short-term ATI and |
NIAID |
N/A |
||
|
In vitro autologous vaccine development to |
UK CPMS17532 (link currently broken) |
Imperial College London/amfAR |
N/A |
N/A |
|
ISALA: Analytical |
Institute of Tropical Medicine, |
N/A |
J Int AIDS Soc. 2020 |
|
|
LoViReT: Low viral reservoir treated patients |
IrsiCaixa |
N/A |
J Intern Med. 2022 |
|
|
MUCOVIR: Exploration of HIV reservoirs |
Objectif Recherche Vaccins SIDA |
N/A |
||
|
PembroHIV: Treatment with immunological |
IrsiCaixa |
N/A |
HIV Persistence Workshop 2019, Abstract PP |
|
|
PITCH: |
NHS Health Research |
University of Oxford |
N/A |
CROI 2022, Abstract 266 |
|
Quantitative measurement and correlates of |
NIAID |
N/A |
JCI Insight. 2020 Jun 16;139287. |
|
|
Role of anti-Tat immunity on disease |
National HIV/AIDS Research Center |
N/A |
||
|
Role of anti-Tat immunity on disease |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
N/A |
||
|
Seroprevalence of anti-Tat antibodies in |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
N/A |
N/A |
|
|
Size of the HIV-1 reservoir and ongoing |
UK CPMS16004 (link currently broken) |
University College London/amfAR |
N/A |
N/A |
|
Specimen repository for HIV |
AIDS Healthcare Foundation |
N/A |
N/A |
|
|
Tissue drug levels of HIV medications |
University of Minnesota – Clinical and |
N/A |
||
|
ULTRASTOP (Towards |
Objectif Recherche VACcin Sida |
N/A |
||
|
VIRECT: Impact of pre-ART CD4 T cell level on the |
Centre Hospitalier Universitaire de Saint |
N/A |
N/A |
|
|
PROTEASOME INHIBITORS |
||||
|
ixazomib |
NCT02946047 |
Mayo Clinic |
Phase I |
|
|
STEM CELL TRANSPLANTATION |
||||
|
HIVECT: HIV |
Puerta de Hierro University |
N/A |
N/A |
|
|
BMT CTN 0903: Allogeneic transplant |
National Heart, Lung, & Blood |
Phase II |
Biol Blood Marrow |
|
|
HLA-mismatched unrelated donor bone marrow |
Center for International Blood and Marrow |
Phase II |
HRSA Advisory Council |
|
|
Immune response after stem cell transplant in |
Fred Hutchinson Cancer Research Center |
Phase II |
N/A |
|
|
Optimized antiretroviral therapy during |
Sidney Kimmel Comprehensive Cancer Center at |
Phase I |
JAIDS 2021 Nov 8. |
|
|
THERAPEUTIC VACCINES |
||||
|
AGS-004 |
Argos Therapeutics |
Phase IIb |
||
|
AGS-004 |
Argos Therapeutics |
Phase IIb |
AIDS Res Hum IAS 2015 Towards an HIV Cure CROI 2014, Poster abstract 344 |
|
|
iHIVARNA-01 |
Rob Gruters, Erasmus Medical |
Phase IIa |
||
|
DermaVir (topically applied DNA vaccine) |
Genetic Immunity |
Phase II |
N/A |
|
|
DermaVir |
Genetic Immunity |
Phase II
|
N/A |
|
|
GSK Biologicals HIV Vaccine 732462 (p24-RT-Nef-p17 |
GlaxoSmithKline |
Phase II |
||
|
GTU-multiHIV + |
Inserm-ANRS |
Phase II
|
J Virol. 2021 |
|
|
Tat protein vaccine |
NCT01513135 |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
Phase II |
|
|
Tat protein vaccine |
NCT00751595 |
Barbara Ensoli, MD, Istituto Superiore di |
Phase II |
Front. Immunol. |
|
Vacc-4x (peptide-based |
Bionor Immuno AS |
Phase II |
||
|
Vacc-4x |
Bionor Immuno AS |
Phase II |
||
|
VAC-3S |
InnaVirVax |
Phase II |
NPJ Vaccines (2019) |
|
|
VAC-3S |
InnaVirVax |
Phase I/IIa |
N/A |
|
|
VAC-3S (peptide-based |
InnaVirVax |
Phase I/IIa |
IAS 2015 Towards an HIV Cure Symposium, Poster abstract PE67 30 Years of HIV Science, 2013, Poster abstract 145 |
|
|
AGS-004 |
University of North Carolina at Chapel |
Phase I/II |
N/A |
|
|
Autologous |
Sharon Riddler, University of |
Phase I/II |
||
|
Dendritic cells |
University of Sao Paulo General Hospital |
Phase I/II |
||
|
Dendritic cell |
Massachusetts General Hospital |
Phase I/II |
N/A |
|
|
Dendritic |
Hospital Clinic of Barcelona |
Phase I/II |
||
|
DermaVir |
AIDS Clinical Trials Group |
Phase I/II |
||
|
GTU®-MultiHIV B clade |
Imperial College London |
Phase I/II |
||
|
p24CE1/2 + p55^gag |
NIAID |
Phase I/II |
N/A |
|
|
PENNVAX-GP or |
Steven Deeks, UCSF |
Phase I/II |
CROI 2022, Abstract 284 |
|
|
Tat Oyi (protein-based |
Biosantech |
Phase I/II |
||
|
THV01 |
Theravectys S.A. |
Phase I/II |
N/A |
|
|
TUTI-16 (synthetic |
Thymon, LLC |
Phase I/II |
||
|
Vacc-C5 (peptide-based |
Bionor Immuno AS |
Phase I/II |
||
|
Ad26.Mos4.HIV + |
Janssen Vaccines & Prevention B.V. |
Phase I |
N/A |
|
|
Ad26.Mos.HIV + |
Janssen Vaccines & Prevention B.V. |
Phase I |
Nat Med March 23, 2020. |
|
|
AFO-18 (peptide-based |
Statens Serum Institut (SSI)/Ministry of the |
Phase I |
||
|
AFO-18 (peptide-based |
SSI/Rigshospitalet/Hvidovre University |
Phase I |
||
|
AT20-KLH |
MED-AT20-001 |
Medestea Research & Production SpA, Turin |
Phase I |
|
|
ChAdV63.HIVcons + MVA.HIVconsv |
IrsiCaixa/Fundació Lluita contra la |
Phase I |
EClinicalMedicine. |
|
|
Dendritic |
Baylor Research Institute/ANRS |
Phase I |
PLoS Pathog. 2019 |
|
|
DermaVir |
Genetic Immunity |
Phase I |
||
|
D-GPE DNA + M-GPE MVA (DNA + viral |
Centers for Disease Control and Prevention, |
Phase I |
N/A |
|
|
DNA.HTI + MVA.HTI + |
Fundacio Lluita |
Phase I |
N/A |
|
|
DNA.HTI + |
Aelix Therapeutics |
Phase I |
CROI 2021, Abstract 161, Webcast |
|
|
HIVAX |
GeneCure Biotechnologies |
Phase I |
Vaccine. 2020;S0264-410X(20)30485-0 |
|
|
HIV-v (peptide-based |
PepTcell Limited |
Phase I |
||
|
iHIVARNA-01 (TriMix |
Biomedical Research Institute August Pi i |
Phase I |
||
|
JS7 DNA + |
GeoVax, Inc. |
Phase I |
||
|
MAG pDNA vaccine +/- IL-12 |
NIAID |
Phase I |
||
|
MAG-pDNA + |
NIAID/Profectus Biosciences, Inc. |
Phase I |
J. Virology May 20, |
|
|
MVA.HIVconsv |
University of Oxford/Medical Research Council |
Phase I |
||
|
PENNVAX-B (Gag, Pol, |
Inovio Pharmaceuticals |
Phase I |
||
|
PENNVAX-B +/- |
University of Pennsylvania |
Phase I |
N/A |
|
|
Recombinant |
China CDC |
Phase I |
N/A |
|
|
rMVA-HIV + rFPV-HIV (viral vector |
NIAID |
Phase I |
||
|
Tat protein vaccine |
NCT00505401 NCT01024595 (extended follow-up |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
Phase I
|
Rev Recent Clin Trials. 2009 Sep;4(3):195-204 Vaccine. 2009 May |
|
TOLL-LIKE RECEPTOR AGONISTS |
||||
|
MGN1703 toll-like receptor 9 (TLR-9) agonist |
University of Aarhus |
Phase Ib/IIa |
EBioMedicine. 2019 Jul |
|
|
Poly-ICLC (TLR-3 agonist) |
Nina Bhardwaj, MD/Campbell |
Phase I/II |
||
|
vesatolimod (TLR-7 |
Gilead Sciences |
Phase Ib |
EACS 2021, CROI 2020, Abstract 40, Webcast |
|
|
vesatolimod (formerly GS-9620) (TLR-7 agonist) |
Gilead Sciences |
Phase Ib |
Clinical Infectious |
|
|
TRADITIONAL CHINESE MEDICINE |
||||
|
Triptolide wilfordii |
Peking Union Medical College |
Phase III |
N/A |
|
|
TREATMENT INTENSIFICATION/EARLY TREATMENT |
||||
|
enfuvirtide |
NIAID |
Not listed |
||
|
enfuvirtide |
Canadian Immunodeficiency Research |
Not listed |
N/A |
|
|
New Era Study: Treatment with |
MUC Research GmbH |
Not listed |
||
|
PLUS: Pilot |
University of California, San Francisco |
Not listed
|
||
|
Anti-HIV medications |
NIAID |
Phase IV |
||
|
DIORR: Dolutegravir impact on residual replication |
University of Melbourne |
Phase IV |
The Lancet HIV, CROI 2018, Abstract 71, Webcast |
|
|
DRONE: Impact of starting a dolutegravir-based |
University Hospital, Strasbourg, France |
Phase IV |
N/A |
|
|
LEOPARD: Latency |
Columbia University |
Phase IV |
Clinical Infectious |
|
|
P25-INACTION: |
Adriano Lazzarin, MD |
Phase IV |
EACS 2021, Abstract BPD4/3 |
|
|
ANRS 147 OPTIPRIM: Optimization of |
Inserm-ANRS |
Phase III |
PLoS One. 2013; 8(3): IAS Cure Symposium 2013, Presentation |
|
|
maraviroc |
Germans Trias i Pujol Hospital |
Phase III |
||
|
raltegravir + |
Centre Hospitalier Intercommunal de Toulon La |
Phase III |
N/A |
|
|
raltegravir |
Germans Trias i Pujol Hospital |
Phase III |
||
|
tenofovir/emtricitabine + dolutegravir |
Inserm/ANRS |
Phase III |
N/A |
|
|
VIRECURE: Impact of extremely early ART to |
David Garcia Cinca, Hospital Clinic of |
Phase III |
N/A |
|
|
Intense acute infection study |
University of Toronto |
Phase II/III |
N/A |
|
|
maraviroc |
Fundación para la Investigación Biomédica del |
Phase II |
||
|
peginterferon alfa-2a (Pegasys) |
Wistar Institute |
Phase II |
EBioMedicine. 2020 Aug 19;59:102945. |
|
|
peginterferon alfa-2b |
University of Pennsylvania/Wistar |
Phase II |
AIDS Res Hum |
|
|
peginterferon alfa-2b |
Wistar Institute |
Phase II |
HIV Persistence Workshop 2019, |
|
|
raltegravir |
Canadian Immunodeficiency Research |
Phase II |
||
|
raltegravir |
Fundación para la Investigación Biomédica del Hospital |
Phase II |
||
|
Viral suppression after analytic treatment interruption |
South East Asia Research Collaboration with |
Phase II |
Nat Med. 2018 |
|
|
alpha interferon intensification |
NIAID |
Phase I/II |
N/A |
|
|
indinavir + |
NIAID |
Phase I |
N/A |
|