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.
January 17, 2020
Table 1. Current Clinical Trials
|
Trial |
Trial Registry Identifier(s) |
Sponsor(s) |
Phase |
Estimated |
|
ADOPTIVE IMMUNOTHERAPY |
||||
|
HST-NEETs: HIV-1 specific T-cells for HIV-infected individuals |
Children’s Research Institute |
Phase I |
December 2021 |
|
|
ANTIBODIES |
||||
|
UB-421 (antibody inhibitor of HIV binding to CD4 receptors) |
United BioPharma |
Phase II |
December 2020 |
|
|
UB-421 |
(not yet open for |
United BioPharma |
Phase II |
March 2021 |
|
vedolizumab (anti-α₄β₇ integrin antibody) |
Hospitales Universitarios Virgen del Rocío |
Phase II |
May 2020 |
|
|
vedolizumab |
Ottawa Hospital Research Institute |
Phase II |
December 2018 |
|
|
PGT121 + VRC07-523LS +/- PGDM1400 |
International AIDS Vaccine Initiative |
Phase I/IIa |
November 2020 |
|
|
VRC01 (broadly neutralizing antibody) in infants |
NIAID |
Phase I/II |
July 2021 |
|
|
VRC01LS + 10-1074 (broadly neutralizing antibodies) in early-treated children |
NIAID |
Phase |
October 2021 |
|
|
10-1074-LS + 3BNC117-LS (long-acting |
Rockefeller University |
Phase I |
June 2021 |
|
|
3BNC117 + 10-1074 (broadly neutralizing antibodies) |
NIAID |
Phase I |
June 2021 |
|
|
3BNC117 + 10-1074 |
Rockefeller University |
Phase I |
May 2020 |
|
|
3BNC117-LS |
Rockefeller University |
Phase I |
August 2020 |
|
|
AAV8-VRC07 (broadly neutralizing |
NIAID
|
Phase I |
March 2020 |
|
|
Elipovimab (formerly GS-9722; PGT121-derived broadly neutralizing antibody) |
GS-US-420-3902 Adisinsight entry (not listed in clinicaltrials.gov) |
Gilead Sciences |
Phase I |
N/A |
|
PGDM1400 +/– PGT121 +/– VRC07-523LS (broadly neutralizing antibodies) |
NCT03205917 |
International AIDS Vaccine Initiative |
Phase I |
December 2020 |
|
SAR441236 (tri-specific broadly neutralizing antibody) |
NIAID |
Phase I |
June 2021 |
|
|
VRC01 + 10-1074 |
NIAID |
Phase I |
March 2024 |
|
|
VRC01LS, VRC07-523LS (long-acting broadly neutralizing |
NCT02840474 |
NIAID |
Phase I |
February 2020 |
|
VRC01 in acute HIV |
NIAID |
Phase I |
June 2020 |
|
|
ANTI-INFLAMMATORY |
||||
|
canakinumab (IL-1β inhibitor) |
University of California, San Francisco |
Phase II |
June 2020 |
|
|
CD24Fc (human CD24 extracellular domain and human IgG1 Fc fusion protein) |
OncoImmune, Inc. |
Phase II |
October 2022 |
|
|
ANTI-PROLIFERATIVE |
||||
|
mycophenolate mofetil (MMF) |
NCT03262441 |
Fred Hutchinson Cancer Research Center |
Phase I |
August 2021 |
|
ANTIRETROVIRAL THERAPY |
||||
|
doravirine |
NCT04079452 |
Fundacio Lluita |
Phase III |
June 2020 |
|
IDOLTIB: Impact of dolutegravir |
NCT04034862 |
University of Liege |
Phase III |
March 2022 |
|
CANNABINOIDS |
|
|
|
|
|
TN-CT11LM, TN-TC19LM oral capsules |
NCT03550352 |
McGill University Health Center |
Phase II |
December 2019 |
|
COMBINATIONS |
||||
|
maraviroc, dolutegravir, dendritic cell vaccine, auranofin, nicotinamide |
NCT02961829 |
Federal University of São Paulo |
Not |
March 2020 |
|
Perturbing of HIV reservoir with immune stimulation: Fluarix, Pneumovax vaccines |
University of California, San Diego |
Not listed |
January 2021 |
|
|
ROADMAP: romidepsin + 3BNC117 |
NCT02850016 |
Rockefeller University |
Phase IIa |
December 2019 |
|
TITAN: lefitolimod + 3BNC117 + 10-1074 (TLR9 agonist + broadly neutralizing |
University of Aarhus |
Phase IIa |
February 2021 |
|
|
eCLEAR: romidepsin + 3BNC117 |
Aarhus University Hospital |
Phase II |
April 2021 |
|
|
MVA HIV-B +/- vedolizumab (viral vector vaccine +/- anti-α₄β₇ integrin antibody) |
NCT04120415 |
French National Agency for Research on AIDS and Viral Hepatitis (Inserm/ANRS) |
Phase II |
December 2021 |
|
Research In Viral Eradication of HIV Reservoirs (RIVER): ART, ChAdV63.HIVconsv & MVA.HIVconsv |
NCT02336074 |
Imperial College London
|
Phase II |
November 2022 |
|
iHIVARNA, MVA vector HIV vaccine, 10-1074, romidepsin, HIVACAR01 (personalized HIV RNA vaccine) |
NCT03619278 |
David Garcia Cinca |
Phase |
July 2020 |
|
IMPAACT P1115 v2.0: Very early intensive treatment of HIV-infected infants to |
IMPAACT |
Phase |
April 2022 |
|
|
panobinostat + pegylated interferon-alpha2a |
Massachusetts General Hospital |
Phase I/II |
February 2020 |
|
|
N-803 (recombinant human super agonist interleukin-15 complex), VRC07-523LS, |
NCT04144335 |
University of Minnesota |
Phase Ib |
December 2020 |
|
Adoptive transfer of haploidentical NK cells and N-803 |
University of Minnesota – Clinical and Translational Science Institute |
Phase I |
September 2020 |
|
|
CD4-ZETA gene–modified T cells +/- interleukin-2 (IL-2) |
NCT01013415 |
University of Pennsylvania |
Phase I |
July 2021 |
|
Chidamide + CAR-T or TCR-T cell therapy |
Guangzhou 8th People’s Hospital |
Phase I |
December 2021 |
|
|
peginterferon alfa-2b + 3BNC117 + 10-1074 |
NCT03588715 |
Wistar Institute |
Phase I |
July 2020 |
|
VRC07-523LS + vorinostat |
University of North |
Phase I |
July 2022 |
|
|
vorinostat + HXTC: HIV 1 antigen expanded specific T cell therapy |
Julia Sung, MD, University of North Carolina, Chapel Hill |
Phase I |
June 2021 |
|
|
vorinostat +/- tamoxifen in postmenopausal women |
NCT03382834 |
NIAID |
Phase I |
June 2023 |
|
CYTOKINES |
||||
|
interleukin-2 (IL2) |
Case Western Reserve University |
Phase II |
December 2021 |
|
|
N-803 |
NCT02191098 |
University of Minnesota – Clinical and Translational Science Institute |
Phase I |
December 2019 |
|
DUAL-AFFINITY RE-TARGETING (DART) MOLECULES |
||||
|
MGD014 |
MacroGenics |
Phase I |
March 2020 |
|
|
GENE THERAPIES |
||||
|
Cal-1: Dual anti-HIV gene transfer construct |
NCT02390297 (closed to |
Calimmune |
Phase I/II |
October 2031 |
|
SB-728-T |
Case Western Reserve University |
Phase I/II |
February 2024 |
|
|
C34-CXCR4 (autologous CD4 T cells gene-modified to express HIV-inhibiting C34 peptide) |
NCT03020524 |
University of Pennsylvania
|
Phase I |
March 2020 |
|
CD4 CAR + SB-728mR modified T cells |
University of Pennsylvania |
Phase I |
December 2025 |
|
|
Chimeric Antigen Receptor (CAR)-T cell therapy |
Guangzhou 8th People’s Hospital |
Phase I |
December 2021 |
|
|
Long-term Follow-up of HIV+ Participants Exposed to SB-728-T or SB-728mR-T |
NCT04201782 |
Sangamo Therapeutics |
Phase |
December 2031 |
|
SB-728mR-HSPC (autologous hematopoietic stem/progenitor cells genetically modified at the CCR5 gene) |
NCT02500849 |
City of Hope Medical Center |
Phase I |
April |
|
shRNA-modified CD34+ cells |
Shanghai Public Health Clinical Center |
Phase I |
January 2020 |
|
|
Anti-gp120 CAR-T cells (autologous T cells gene-modified to express a chimeric antigen receptor targeting HIV gp120) |
ChiCTR-OPN-17013068 |
Jinyintan Hospital of WuHan |
Phase 0 |
December 2018 |
|
GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS |
||||
|
CRISPR CCR5 modified CD34+ cells |
307 Hospital of PLA (Affiliated Hospital of Academy to Military Medical Sciences) |
Not |
May 2021 |
|
|
Stem cells gene-modified with Cal-1 |
Assistance Publique – Hôpitaux de Paris |
Phase |
January |
|
|
Stem cells gene-modified with CCR5 shRNA/TRIM5alpha/TAR decoy |
AIDS Malignancy Consortium |
Phase I/II |
June 2036 |
|
|
Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) |
NCT02337985 |
City of Hope Medical Center |
Phase I |
June 2022 |
|
Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) + busulfan |
NCT01961063 |
City of Hope Medical Center |
Phase I |
June 2031 |
|
GONADOTROPIN-RELEASING HORMONE (GnRH) AGONISTS |
||||
|
triptorelin acetate depot |
Immune System Regulation AB |
Phase II |
May 2020 |
|
|
HORMONES |
||||
|
somatotropin (human growth hormone) |
McGill University Health Center |
Phase II |
December 2020 |
|
|
IMAGING STUDIES |
||||
|
123I radiolabeled 3BNC117 |
NCT03468582 |
University of Lausanne Hospitals |
Phase I |
February 2019 |
|
Imaging immune activation in HIV by PET-MR |
University of California, San Francisco |
Phase I |
June 2020 |
|
|
Radiolabeled 3BNC117 + Copper-64 radio isotope followed by MRI/PET scanning to detect HIV in vivo |
Bayside Health |
Phase I |
July 2019 |
|
|
Radiolabeled VRC01 |
University of California, San Francisco |
Phase I |
October 2019 |
|
|
IMMUNE CHECKPOINT INHIBITORS |
||||
|
durvalumab (anti-PD-L1 antibody) in solid tumors |
NCT03094286 |
Spanish Lung Cancer Group |
Phase II |
April 2022 |
|
cemiplimab (anti-PD-1 antibody) |
NCT03787095 |
NIAID |
Phase I/II |
December 2021 |
|
budigalimab (anti-PD-1 antibody) |
NCT04223804 |
AbbVie |
Phase Ib |
December 2021 |
|
nivolumab (anti-PD-1 antibody) + ipilimumab (anti-CTLA-4 antibody) in treating patients with advanced HIV associated solid tumors |
National Cancer Institute (NCI) |
Phase I |
December 2020 |
|
|
pembrolizumab (anti-PD-1 antibody) in treating patients with HIV and relapsed, refractory, or disseminated |
National Cancer Institute (NCI) |
Phase I |
July 2020 |
|
|
pembrolizumab (anti-PD-1 antibody) single dose |
National Institute of Neurological Disorders and Stroke (NINDS) |
Phase I |
December 2020 |
|
|
LATENCY-REVERSING AGENTS |
||||
|
Chidamide |
NCT02902185 |
Tang-Du Hospital |
Phase II/III |
December 2018 |
|
valproic acid + |
Erasmus Medical Center |
Phase I/II |
April 2020 |
|
|
arsenic trioxide |
Guangzhou 8th People’s Hospital |
Phase I |
December 2021 |
|
|
Kansui (traditional Chinese |
UCSF |
Phase I |
December 2020 |
|
|
PROTEASOME INHIBITORS |
||||
|
ixazomib |
NCT02946047 |
Mayo Clinic |
Phase I/II |
September 2020 |
|
RETINOIDS |
||||
|
acitretin |
NCT03753867 |
Ottawa Hospital Research Institute |
Phase I |
May 2019 |
|
STEM CELL TRANSPLANTATION |
||||
|
HIVECT: HIV eradication through cord-blood transplantation |
Puerta de Hierro University Hospital |
N/A |
December 2018 |
|
|
IMPAACT P1107: Cord blood transplantation using CCR5-Δ32 donor cells for the treatment of HIV and |
International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) |
N/A |
March 2023 |
|
|
Cord blood transplant with OTS for the treatment of HIV+ hematologic cancers |
NCT04083170 |
Fred Hutchinson Cancer Research Center |
Phase II |
December 2022 |
|
HLA-mismatched unrelated donor bone marrow transplantation |
NCT02793544 |
Center for International Blood and Marrow Transplant Research |
Phase II |
April 2020 |
|
STIMULANTS |
||||
|
EMRLHD: Effect of methamphetamine on residual latent HIV disease study |
University of California, San Francisco |
Phase IV |
August 2023 |
|
|
THERAPEUTIC VACCINES |
||||
|
p24CE1/2 + p55^gag conserved-element DNA vaccines |
NCT03560258 |
NIAID |
Phase I/II |
September 2020 |
|
PENNVAX-GP or INO-6145 + IL-12 DNA adjuvant (INO-9012) (DNA vaccines) |
Steven Deeks, UCSF |
Phase I/II |
December 2020 |
|
|
Ad26.Mos4.HIV + MVA-Mosaic or clade C gp140 + mosaic gp140 (viral vector vaccines + proteins) |
Janssen Vaccines & Prevention B.V. |
Phase I |
February 2022 |
|
|
DC-HIV04: a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides |
Sharon Riddler, University of Pittsburgh |
Phase I |
May 2022 |
|
|
DNA.HTI + MVA.HTI (DNA + viral vector vaccines) |
NCT03204617 |
Aelix Therapeutics |
Phase I |
September 2020 |
|
MVA.tHIVconsv3 +/- MVA.tHIVconsv4 (viral vector vaccines) |
University of North Carolina, Chapel Hill |
Phase I |
August 2020 |
|
|
TOLL-LIKE RECEPTOR AGONISTS |
||||
|
vesatolimod (TLR-7 agonist) in ART-treated HIV controllers |
NCT03060447 |
Gilead Sciences |
Phase Ib |
February 2020 |
|
TREATMENT INTENSIFICATION/EARLY TREATMENT |
||||
|
P25-INACTION: Implication for strategies |
Adriano Lazzarin, MD |
Phase |
June 2021 |
|
|
LEOPARD: Latency and early neonatal provision of antiretroviral drugs clinical trial |
NCT02431975 |
Columbia University |
Phase IV |
July 2020 |
|
Antiretroviral regime for viral eradication in newborns |
National Center for Women and Children’s Health, China CDC |
Phase IV |
December 2019 |
|
|
DGVTAF: Immediate initiation of antiretroviral therapy during “hyperacute” HIV infection |
UCSF |
Phase IV |
April 2020 |
|
|
AAHIV/RV254: Antiretroviral therapy for acute HIV infection |
South East Asia Research Collaboration with Hawaii |
Phase III |
June 2033 |
|
|
tenofovir/emtricitabine + dolutegravir or tenofovir/emtricitabine + darunavir/cobicistat |
NCT02987530 |
Inserm/ANRS |
Phase III |
December 2019 |
|
EIT: Early infant HIV treatment in Botswana |
Harvard School of Public Health |
Phase II/III |
July 2021 |
|
|
EARLIER: Early ART to limit infection |
AIDS Clinical Trials |
Phase II |
May 2021 |
|
Table 2. Observational Studies
|
Trial |
Trial |
Manufacturer/ |
Phase |
Estimated |
|
2000HIV: 2000 HIV Human |
NCT03994835 |
Radboud University |
N/A |
December 2023 |
|
Accurate staging of immuno-virological dynamics during acute HIV infection (ACS) |
University Hospital, Ghent |
N/A |
January 2023 |
|
|
Analytic treatment interruption (ATI) to assess HIV cure |
NCT02437526 |
Mayo Clinic |
N/A |
|
|
ANRS CO24 OncoVIHAC: Immune checkpoint inhibitors in HIV+ individuals with cancers |
Inserm-ANRS |
N/A |
June 2022 |
|
|
ANRS EP63: A chronological study of the formation of HIV cellular reservoirs through the expression of surface markers on CD4+ T lymphocytes, including CD32a |
Inserm-ANRS |
N/A |
June 2020 |
|
|
ATGALIG-HIV: Study of autophagy and the effects of GALIG gene products in HIV-1+ patients on antiretroviral therapy since primary infection, chronic phase, or never treated |
Centre Hospitalier Régional d’Orléans |
N/A |
November 2029 |
|
|
Biomarkers to predict time to plasma HIV RNA rebound (ACTG A5345) |
AIDS Clinical Trials Group |
N/A |
September 2020 |
|
|
CLEAC: Comparison of late versus early antiretroviral therapy in HIV-infected children |
NCT02674867 |
Inserm-ANRS |
N/A |
June 2019 |
|
CODEX (the “Extreme” cohort, ANRS CO21) |
Inserm-ANRS |
N/A |
September 2023 |
|
|
Developing a functional cure for HIV disease: Clinical specimen collection from HIV+ individuals |
American Gene Technologies International Inc. |
N/A |
December 2019 |
|
|
DOLUVOIR: Cartography of virologic reservoir related to antiretroviral concentrations in HIV-1+ patients on first line treatment containing dolutegravir and associated |
NCT04133012 |
Inserm-ANRS |
N/A |
November 2020 |
|
Establish and characterize an acute HIV infection cohort in a high-risk population |
Southeast Asia Research Collaboration with Hawaii/Armed Forces Research Institute of Medical Sciences/Thai Red Cross AIDS Research Centre |
N/A |
July 2033 |
|
|
FRESH (Females rising through education, support, and health) |
Ragon Institute |
Ragon Institute of MGH, MIT and Harvard |
N/A
|
|
|
FXReservoir: Study of the effects of farnesoid X receptor (FXR) ligands on the reactivation of latent provirus |
Hospices Civils de Lyon |
N/A |
December 2019 |
|
|
Genotyping FcɣRs genes |
University Hospital, Strasbourg, France |
N/A |
February 2020 |
|
|
HEATHER: HIV reservoir targeting with early antiretroviral therapy |
UK CPMS17589 |
University of Oxford/Medical Research Council/British HIV Association |
N/A |
September 2019 |
|
HIV-PRADA: HIV persistence in lymph node and peripheral blood |
NCT03426189 |
University of Melbourne |
N/A |
January 2020 |
|
Host & viral factors associated with HIV elite control |
UK CPMS16146 |
University College London Hospitals NHS Foundation Trust |
N/A |
May 2021 |
|
HSCT-HIV: Allogeneic hematopoietic |
Kirby Institute |
N/A |
September 2024 |
|
|
HUSH restriction in HIV+ patients |
Inserm-ANRS |
N/A |
September 2022 |
|
|
iCHIP: Effect of immune checkpoint inhibitors on HIV persistence |
hivcure.com.au (no registry entry) |
University of Melbourne |
N/A |
N/A |
|
IciStem: Collaborative project to guide and investigate the potential for HIV cure in HIV+ patients requiring allogeneic stem cell transplantation for hematological disorders |
IciStem website (no |
amfAR |
N/A |
N/A |
|
Identification and quantification of HIV CNS latency biomarkers |
St Vincent’s
|
N/A |
December 2020 |
|
|
IMPAACT 2015: Evaluation of the HIV-1 reservoir in the CNS of perinatally-infected youth and young adults with cognitive impairment |
NCT03416790 |
IMPAACT |
N/A |
January 2020 |
|
Impact of a short-term analytical treatment interruption and re-initiation of antiretroviral therapy on immunologic and virologic parameters in HIV+ individuals |
NCT03225118 |
NIAID |
N/A |
July 2020 |
|
Impact of ART adherence on HIV persistence and inflammation |
NCT02797093 |
University of Colorado, Denver |
N/A |
October 2020 |
|
Long-term effects of ART in acute HIV infection |
ChiCTR1800015006 |
Key Laboratory of AIDS Immunology of National Health and Family Planning Commission, Department of Laboratory Medicine, The First Affiliated Hospital, China Medical University |
N/A |
December 2020 |
|
Measurement for viral reservoir and immune function in HIV-1+ patients under antiretroviral therapy |
National Taiwan University Hospital |
N/A |
August 2019 |
|
|
PembroHIV: Treatment with |
IrsiCaixa |
N/A |
October 2019 |
|
|
PITCH: Prospective interruption of therapy towards a cure for HIV pilot study |
NHS Health Research |
University of Oxford |
N/A |
N/A |
|
Post analytic treatment interruption study |
South East Asia Research Collaboration with Hawaii |
N/A |
July 2020 |
|
|
PRIMO (ANRS CO6): Primary infection cohort |
Inserm-ANRS |
N/A |
December 2020 |
|
|
Quantitative measurement and correlates of the latent HIV reservoir in virally suppressed Ugandans |
NCT02154035 |
NIAID |
N/A |
February 2020 |
|
RESERVIH32: Bioclinical evaluation of two biomarkers of aviremic HIV-1 in CD4 T cells of adults undergoing treatment |
NCT03940521 (not yet open for enrollment) |
Centre Hospitalier Universitaire de Nīmes |
N/A |
September 2020 |
|
Role of the IL-33/amphiregulin pathway as a potential therapeutic target in HIV infection |
Inserm-ANRS |
N/A |
September 2023 |
|
|
Specimen repository for HIV immunopathogenesis |
AIDS Healthcare Foundation |
N/A |
December 2020 |
|
|
TESOVIR: Tracking and exploring the source of viral rebound (ART interruption) |
Centre Hospitalier Régional d’Orléans |
N/A |
September 2022 |
|
|
The Last Gift Study (for people with HIV and less than 6 months life expectancy due to terminal illness) |
University of California, San Diego (UCSD) |
N/A |
N/A |
|
|
The use of leukapheresis to support HIV pathogenesis studies |
University of California, San Francisco |
N/A |
July 2020 |
|
|
Thinking and memory problems in people with HIV |
National Institute of Neurological Disorders and Stroke (NINDS) |
N/A |
February 2027 |
|
|
TRESAX: T follicular helper reservoir in axillary lymph nodes study |
hivcure.com.au (no registry entry) |
University of Melbourne |
N/A |
N/A |
Table 3. Completed Studies
|
Trial |
Trial |
Manufacturer/ |
Phase |
Published/Presented |
|
ADOPTIVE IMMUNOTHERAPY |
||||
|
Early ART in combination with autologous HIV-specific cytotoxic T lymphocyte (CTL) infusion |
Yongtao Sun, MD, PhD, Tangdu Hospital, the Fourth Military Medical University |
Phase III |
N/A |
|
|
Reconstitution of HIV-specific immunity against HIV |
Guangzhou 8th People’s Hospital |
Phase I/II |
N/A |
|
|
HIV-specific |
Beijing You’an Hospital, Capital Medical University |
Phase I |
||
|
HXTC: HIV 1 |
University of North Carolina, Chapel Hill |
Phase I |
||
|
ANTIBODIES |
||||
|
CHERUB 001 |
No clinicaltrials.gov |
CHERUB (Collaborative HIV Eradication of viral Reservoirs: UK BRC) |
N/A |
|
|
3BNC117 (broadly neutralizing monoclonal antibody) |
NCT02446847 |
Rockefeller University |
Phase II |
|
|
3BNC117 |
Rockefeller University |
Phase II |
N/A |
|
|
UB-421 (antibody inhibitor of HIV binding to CD4 receptors) |
United BioPharma |
Phase II |
||
|
VRC01 (broadly neutralizing monoclonal antibody) |
NCT02664415 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Phase II |
IAS 2017, Abstract TUAB0106LB (slides, video) |
|
10-1074 (broadly neutralizing monoclonal antibody) |
Rockefeller University |
Phase I |
||
|
3BNC117 |
Rockefeller University |
Phase I |
||
|
3BNC117 + 10-1074 |
Rockefeller University |
Phase I |
||
|
PGT121 |
International AIDS Vaccine Initiative |
Phase I |
CROI 2019, Abstract 145, Webcast |
|
|
vedolizumab |
NIAID |
Phase I |
AIDS 2018, WESS0102 |
|
|
VRC01 |
NIAID |
Phase I |
N/A |
|
|
VRC01 |
NIAID |
Phase I |
||
|
VRC01 |
NIAID |
Phase I |
N Engl J Med. 2016 |
|
|
VRC01 |
NIAID |
Phase I |
||
|
ANTI-FIBROTIC |
||||
|
ACE inhibitors |
UCSF/amfAR |
Phase IV |
||
|
losartan |
University of Minnesota |
Phase II |
N/A |
|
|
telmisartan |
AIDS Clinical Trials Group |
Phase II |
CROI 2019, Abstract 395 |
|
|
telmisartan |
Yale University |
Phase I |
CROI 2019, Abstract 300 |
|
|
ANTI-INFLAMMATORY |
||||
|
High dose vitamin D supplementation |
University of Melbourne |
Phase II |
N/A |
|
|
CC-11050 (phosphodiesterase-4 inhibitor) |
NIAID |
Phase I |
AIDS 2018, Poster abstract |
|
|
ANTIRETROVIRAL THERAPY |
||||
|
dolutegravir in reservoirs |
Emory University |
Phase N/A |
||
|
HIV reservoir dynamics after switching to dolutegravir in patients on a PI/r based regimen |
Hospital Universitari Vall d’Hebron Research Institute |
Phase IV |
N/A |
|
|
raltegravir or efavirenz + tenofovir + emtricitibine |
University of Alabama at Birmingham |
Phase IV |
N/A |
|
|
ABX464 |
Abivax S.A. |
Phase II |
||
|
ABX464 |
Abivax S.A. |
Phase I/II
|
9th HIV Persistence 16th European Meeting |
|
|
ANTIRETROVIRAL THERAPY IN HIV CONTROLLERS |
||||
|
emtricitabine + rilpivirine + tenofovir |
AIDS Clinical Trials Group/NIAID |
Phase IV |
Clin Infect Dis. 2019 |
|
|
raltegravir + tenofovir + emtricitabine |
University of California, San Francisco |
Phase IV |
||
|
ASSEMBLY INHIBITORS |
||||
|
BIT225 |
Biotron Limited |
Phase II |
||
|
BIT225 |
Biotron Limited |
Phase I |
||
|
COMBINATIONS |
||||
|
chemotherapy + maraviroc in people with non-Hodgkin lymphoma |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
Phase 0 |
Terminated due to |
|
|
Adoptive transfer of haploidentical natural killer cells and IL-2 |
University of Minnesota – Clinical and Translational Science Institute |
Phase II |
N/A |
|
|
ERAMUNE-01 (antiretroviral intensification +/- interleukin-7) |
ORVACS/Cytheris SA/Merck Sharp & Dohme Corp./Pfizer |
Phase II |
||
|
ERAMUNE-02 (DNA/Ad5 vaccine, ART |
|
Vical/GenVec/CHERUB/NIH Vaccine Research Center/ORVACS |
Phase II |
Lancet HIV. 2015 CROI 2014, Poster abstract 422 |
|
disulfiram + vorinostat |
NCT03198559 |
The Peter Doherty Institute for Infection and Immunity |
Phase I/II |
CROI 2019, Abstract 401 |
|
GTU-MultiHIV B-clade + MVA HIV-B +/- vedolizumab (DNA + viral vector vaccines +/- anti-α₄β₇ |
Inserm-ANRS |
Phase I/II |
Terminated due to the |
|
|
Vacc-4x + romidepsin |
Bionor Immuno AS/Celgene |
Phase I/II
|
CROI 2019, Abstract 397 |
|
|
Vacc-4x (peptide-based therapeutic vaccine) + |
Bionor Immuno AS |
Phase I/II |
IAS 2015 Towards an |
|
|
vorinostat + hydroxychloroquine + maraviroc (VHM) |
NCT02475915 |
South East Asia Research Collaboration with Hawaii |
Phase I/II |
AIDS 2016, Abstract TUAX0101LB |
|
AGS-004 + vorinostat |
NIAID |
Phase I |
Terminated (Argos |
|
|
DCV3 (dendritic cell-based vaccine pulsed with autologous inactivated HIV) + pegylated interferon |
Judit Pich Martínez, Fundació Clínic per la Recerca Biomèdica |
Phase I |
||
|
MVA-B (viral vector vaccine) +/- disulfiram |
Hospital Clinic of Barcelona/HIVACAT |
Phase I |
||
|
MVA.HIVconsv + romidepsin |
IrsiCaixa |
Phase I
|
CROI 2019, Abstract 438 |
|
|
GENE THERAPIES |
||||
|
OZ1 |
Janssen-Cilag Pty Ltd |
Phase II |
||
|
Cal-1: Dual anti-HIV gene transfer construct |
Calimmune |
Phase I/II |
N/A
|
|
|
SB-728mR-T (autologous CD4 T cells genetically modified at the CCR5 gene) + cyclophosphamide |
Sangamo BioSciences |
Phase I/II |
N/A |
|
|
SB-728-T + cyclophosphamide |
Sangamo BioSciences |
Phase I/II
|
CROI 2016, Poster abstract 358LB CROI 2015, Poster abstract 434 CROI 2014, Abstract |
|
|
SB-728-T |
Sangamo BioSciences |
Phase I/II |
N/A |
|
|
VRX496 (gene-modified autologous CD4 T cells) |
University of Pennsylvania |
Phase I/II |
||
|
HGTV43 |
No clinicaltrials.gov |
Enzo Biochem |
Phase I |
AIDS 2006, Abstract MOPDA06 |
|
MazF-T (redirected MazF-CD4 autologous T cells) |
Takara Bio/University of Pennsylvania |
Phase I |
CROI 2015, Poster abstract 402 |
|
|
Redirected high affinity Gag-specific T cells |
University of Pennsylvania/Adaptimmune |
Phase I |
Study closed due to |
|
|
SB-728mR-T + cyclophosphamide |
University of Pennsylvania |
Phase I |
CROI 2019, Abstract |
|
|
SB-728-T |
Sangamo BioSciences |
Phase I |
ICAAC 2014, Abstract |
|
|
SB-728-T
|
Sangamo Biosciences/University of Pennsylvania |
Phase I |
||
|
GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS |
||||
|
Stem cells gene-modified with M87o vector encoding HIV-inhibiting C46 peptide |
Universitätsklinikum Hamburg-Eppendorf |
Phase I/II |
N/A |
|
|
Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) |
City of Hope Medical Center |
Phase I |
||
|
IMMUNE CHECKPOINT INHIBITORS |
||||
|
BMS-936559 (anti-PD-L1 antibody) |
National Institute of Allergy and Infectious Diseases (NIAID) |
Phase I |
J Infect Dis. 2017 CROI 2016, Abstract |
|
|
ipilimumab (anti-CTLA-4 antibody) |
Medarex |
Phase I |
||
|
IRON CHELATORS |
||||
|
deferiprone |
ApoPharma |
Phase I |
N/A |
|
|
JANUS KINASE INHIBITORS |
||||
|
ruxolitinib |
NIAID |
Phase II |
CROI 2019, Abstract |
|
|
LATENCY-REVERSING AGENTS |
||||
|
disulfiram |
University of California, San Francisco/ |
Not specified |
||
|
vorinostat (HDAC inhibitor) |
Bayside Health/Merck |
Phase II |
||
|
valproic acid (HDAC inhibitor) |
McGill University/Canadian Foundation for AIDS Research/CIHR Canadian HIV Trials |
Phase II |
||
|
valproic acid |
University of North Carolina at Chapel Hill/NIAID/Abbott/Merck Sharp & Dohme |
Phase II
|
||
|
Chidamide (HDAC inhibitor) |
Tang-Du Hospital |
Phase I/II |
||
|
disulfiram (acetaldehyde dehydrogenase inhibitor) |
University of California, San Francisco/Monash University/amfAR |
Phase I/II |
CROI 2015, Poster abstract 428LB |
|
|
panobinostat (HDAC inhibitor) |
University of Aarhus/Massachusetts General Hospital/Monash University/Karolinska Institutet/ |
Phase I/II |
CROI 2015, Abstract |
|
|
romidepsin (HDAC inhibitor) |
AIDS Clinical Trials |
Phase I/II
|
CROI 2019, Abstract |
|
|
vorinostat |
University of North Carolina at Chapel Hill/NIAID/Merck |
Phase I/II |
J Clin Invest. 2017 Aug 1;127(8):3126-3135. |
|
|
bryostatin 1 (PKC agonist) |
Fundacion para la |
Phase I |
||
|
mTOR INHIBITORS |
||||
|
Impact of Everolimus on HIV persistence post kidney or liver transplant |
UCSF |
Phase IV |
N/A |
|
|
Sirolimus |
ACTG |
Phase I/II |
CROI 2019, Abstract 131, |
|
|
metformin |
McGill University Health Center |
Phase I |
CROI 2019, Poster abstract 301 |
|
|
OBSERVATIONAL STUDIES |
||||
|
ACTG A5321: Decay of HIV-1 reservoirs in subjects on long-term antiretroviral therapy: The ACTG HIV reservoirs |
N/A |
AIDS Clinical Trials Group |
N/A
|
9th HIV Persistence CROI 2018, Abstract 119, Webcast |
|
ANRS EP 44: Residual replication of HIV-1 in the gut associated lymphoid tissue (GALT) |
Inserm-ANRS |
N/A |
N/A |
|
|
APACHE: Monitored antiretroviral pause in chronically infected HIV+ individuals with long-lasting |
Ospedale San Raffaele |
N/A |
9th HIV Persistence |
|
|
CHERUB 003 |
Imperial College London/CHERUB |
N/A |
N/A |
|
|
Effects of dolutegravir based regimen on HIV-1 reservoir and immune activation |
University Hospital, Strasbourg, France |
N/A |
||
|
EPIC4: Early Pediatric Initiation: Canada Child cure Cohort Study |
Canadian Institutes of Health Research (CIHR)/Canadian Foundation for AIDS Research (CANFAR)/International AIDS Society (IAS) |
N/A
|
Clin Infect Dis. 2019 |
|
|
EURECA: Exploratory study of cellular reservoirs in blood |
Centre Hospitalier Universitaire de Besancon |
N/A |
||
|
HCURE: Analysis of the impact of HCV treatment by last generation direct antiviral agents (DAA) on |
Assistance Publique Hopitaux De Marseille |
N/A |
N/A |
|
|
HIV resistance and treatment strategies |
NIAID |
N/A |
N/A |
|
|
HIV-STAR: HIV sequencing after treatment interruption to identify the clinically relevant anatomical |
University Hospital, Ghent
|
N/A |
Cell Host Microbe. |
|
|
ImmunoCo27: Co-adaptation between HIV and CD8 cellular immunity |
Inserm-ANRS |
N/A |
N/A |
|
|
In vitro autologous vaccine development to activate HIV reservoirs |
UK CPMS17532 (link |
Imperial College London/amfAR |
N/A |
N/A |
|
ISALA: Analytical treatment interruption in HIV positive patients |
Institute of Tropical Medicine, Belgium |
N/A |
CROI 2019, Poster abstract 389, Webcast |
|
|
LoViReT: Low viral reservoir treated patients |
IrsiCaixa |
N/A |
9th HIV Persistence |
|
|
MUCOVIR: Exploration of HIV reservoirs |
Objectif Recherche Vaccins SIDA |
N/A |
||
|
Role of anti-Tat immunity on disease progression in HIV+ asymptomatic adults |
National HIV/AIDS Research Center (CNAIDS), Istituto Superiore di Sanità, Rome, Italy |
N/A |
||
|
Role of anti-Tat immunity on disease progression in HIV+ cART-treated adults |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
N/A |
N/A |
|
|
Seroprevalence of anti-Tat antibodies in HIV-infected South African patients |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
N/A |
N/A |
|
|
Size of the HIV-1 reservoir and ongoing replication in defined cohorts |
UK CPMS16004 (link |
University College London/amfAR |
N/A |
N/A |
|
Tissue drug levels of HIV medications |
University of Minnesota – Clinical and Translational Science Institute/NIAID |
N/A |
||
|
ULTRASTOP (Towards HIV Functional Cure) ERAMUNE-03 (antiretroviral treatment interruption) |
Objectif Recherche VACcin Sida (ORVACS)/Fondation Bettencourt Schueller |
N/A |
||
|
VIRECT: Impact of pre-ART CD4 T cell level on the rectal reservoir in long-term HIV-1 treated men |
Centre Hospitalier Universitaire de Saint Etienne |
N/A |
N/A |
|
|
STEM CELL TRANSPLANTATION |
||||
|
BMT CTN 0903: Allogeneic transplant in individuals with chemotherapy-sensitive hematologic malignancies and |
National Heart, Lung, & Blood Institute/National Cancer Institute/Blood & Marrow Transplant |
Phase II |
Biol Blood Marrow Transplant. |
|
|
Immune response after stem cell transplant in HIV-positive patients with hematologic cancer |
Fred Hutchinson Cancer Research Center |
Phase II |
N/A |
|
|
THERAPEUTIC VACCINES |
||||
|
AGS-004 (personalized therapeutic vaccine utilizing patient-derived dendritic cells and HIV antigens) |
Argos Therapeutics |
Phase IIb |
||
|
AGS-004 |
Argos Therapeutics |
Phase IIb |
AIDS Res Hum Retroviruses. IAS 2015 Towards an CROI 2014, Poster abstract 344 |
|
|
iHIVARNA-01 (TriMix & HIV antigen naked messenger RNA) |
Rob Gruters, Erasmus Medical Center |
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 + LIPO-5 (DNA + lipopeptide vaccines) |
Inserm-ANRS |
Phase II
|
J Infect Dis. 2019 |
|
|
Tat protein vaccine |
NCT01513135 |
CNAIDS, Istituto Superiore di Sanità, Rome, Italy |
Phase II |
|
|
Tat protein vaccine |
NCT00751595 |
Barbara Ensoli, MD, Istituto Superiore di Sanità |
Phase II |
Front. Immunol. |
|
Vacc-4x (peptide-based vaccine) |
Bionor Immuno AS |
Phase II |
||
|
Vacc-4x |
Bionor Immuno AS |
Phase II |
||
|
VAC-3S (peptide-based vaccine) |
InnaVirVax |
Phase II |
NPJ Vaccines (2019) |
|
|
VAC-3S |
InnaVirVax |
Phase I/IIa |
N/A |
|
|
VAC-3S (peptide-based vaccine) |
InnaVirVax |
Phase I/IIa |
IAS 2015 Towards an 30 Years of HIV |
|
|
AGS-004 |
University of North Carolina at Chapel Hill/Argos Therapeutics/U.S. National Institutes of Health |
Phase I/II |
N/A |
|
|
Autologous HIV-1 ApB DC Vaccine |
Sharon Riddler, |
Phase I/II |
||
|
Dendritic cells pulsed with chemically inactivated HIV |
University of Sao Paulo General Hospital |
Phase I/II |
||
|
Dendritic cell vaccine |
Massachusetts General Hospital |
Phase I/II |
N/A |
|
|
Dendritic cell vaccine (DCV-2) |
Hospital Clinic of Barcelona |
Phase I/II |
||
|
DermaVir |
AIDS Clinical Trials Group |
Phase I/II |
||
|
GTU®-MultiHIV B Clade Vaccine |
Imperial College London |
Phase I/II |
||
|
Tat Oyi (protein-based vaccine) |
Biosantech |
Phase I/II |
||
|
THV01 (lentiviral vector-based therapeutic vaccine) |
Theravectys S.A. |
Phase I/II |
N/A |
|
|
TUTI-16 (synthetic HIV-1 Tat epitope vaccine) |
Thymon, LLC |
Phase I/II |
||
|
Vacc-C5 (peptide-based vaccine) |
Bionor Immuno AS |
Phase I/II |
||
|
Ad26.Mos.HIV + MVA-Mosaic |
Janssen Vaccines & Prevention B.V. |
Phase I |
IAS 2019 HIV & |
|
|
AFO-18 (peptide-based vaccine) |
Statens Serum Institut (SSI)/Ministry of the Interior and Health, Denmark/European and |
Phase I |
||
|
AFO-18 (peptide-based vaccine) |
SSI/Rigshospitalet/Hvidovre University Hosp./Ministry of Interior & Health, Denmark |
Phase I |
||
|
AT20-KLH |
MED-AT20-001 |
Medestea Research & Production SpA, Turin |
Phase I |
|
|
ChAdV63.HIVcons + MVA.HIVconsv (viral vector vaccines) |
IrsiCaixa/Fundació |
Phase I |
EClinicalMedicine. |
|
|
Dendritic cells loaded with HIV-1 lipopeptides |
Baylor Research Institute/ANRS |
Phase I |
PLoS Pathog. 2019 Sep |
|
|
DermaVir |
Genetic Immunity |
Phase I |
||
|
D-GPE DNA + M-GPE MVA (DNA + viral vector vaccines) |
Centers for Disease Control and Prevention, China |
Phase I |
N/A |
|
|
HIVAX (lentiviral vector-based therapeutic vaccine) |
GeneCure Biotechnologies |
Phase I |
||
|
HIV-v (peptide-based vaccine) |
PepTcell Limited |
Phase I |
||
|
iHIVARNA-01 (TriMix & HIV antigen naked messenger RNA) |
Biomedical Research Institute August Pi i Sunyer (IDIBAPS) |
Phase I |
||
|
JS7 DNA + MVA62B (DNA + viral vector vaccines) |
GeoVax, Inc. |
Phase I |
||
|
MAG pDNA vaccine +/- IL-12 |
NIAID |
Phase I |
N/A |
|
|
MAG-pDNA + rVSVIN HIV-1 Gag (DNA + viral vector |
NIAID/Profectus Biosciences, Inc. |
Phase I |
CROI 2019, Poster abstract 392, Webcast |
|
|
MVA.HIVconsv |
University of Oxford/Medical Research Council |
Phase I |
N/A |
|
|
PENNVAX-B (Gag, Pol, Env) + electroporation |
Inovio Pharmaceuticals |
Phase I |
||
|
PENNVAX-B +/- IL-12 or IL-15 |
University ofPennsylvania |
Phase I |
N/A |
|
|
Recombinant |
Centers for Disease |
Phase I |
N/A |
|
|
rMVA-HIV + rFPV-HIV (viral vector vaccines) in young adults |
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 |
|
|
Poly-ICLC (TLR-3 agonist) |
Nina Bhardwaj, MD/Campbell Foundation/Oncovir, Inc. |
Phase I/II |
||
|
vesatolimod (formerly GS-9620) (TLR-7 agonist) |
Gilead Sciences |
Phase Ib |
IAS 2019, Abstract WEAA0304 (slides) |
|
|
TRADITIONAL CHINESE MEDICINE |
||||
|
Triptolide wilfordii |
Peking Union Medical |
Phase III |
N/A |
|
|
TREATMENT INTENSIFICATION/EARLY TREATMENT |
||||
|
enfuvirtide |
NIAID |
Not listed |
||
|
enfuvirtide |
Canadian Immunodeficiency Research Collaborative |
Not listed |
N/A |
|
|
New Era Study: Treatment with multi–drug class (MDC) |
MUC Research GmbH |
Not listed |
||
|
PLUS: Pilot study on the effect of adding raltegravir +/- a second drug on HIV levels in the gut |
University of California, San Francisco |
Not listed
|
||
|
Anti-HIV medications for people recently infected with HIV |
NIAID |
Phase IV |
||
|
DIORR: Dolutegravir impact on residual replication |
University of Melbourne |
Phase IV |
The Lancet HIV, CROI 2018, Abstract |
|
|
DRONE: Impact of starting a dolutegravir-based regimen on HIV-1 proviral DNA reservoir of treatment |
University Hospital, Strasbourg, France |
Phase IV |
N/A |
|
|
ANRS 147 OPTIPRIM: Optimization of primary HIV-1 infection treatment |
Inserm-ANRS |
Phase III |
PLoS One. 2013; 8(3): IAS Cure Symposium |
|
|
maraviroc |
Germans Trias i Pujol Hospital |
Phase III |
||
|
raltegravir + maraviroc |
Centre Hospitalier Intercommunal de Toulon La |
Phase III |
N/A |
|
|
raltegravir |
Germans Trias i Pujol Hospital |
Phase III |
||
|
VIRECURE: Impact of extremely early ART to reduce viral reservoir & induce functional cure of HIV infection |
David Garcia Cinca, Hospital Clinic of Barcelona |
Phase III |
N/A |
|
|
Intense acute infection study |
University of Toronto |
Phase II/III |
N/A |
|
|
maraviroc |
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal/Pfizer |
Phase II |
||
|
peginterferon alfa-2a (Pegasys) |
Wistar Institute |
Phase II |
||
|
peginterferon alfa-2b |
University of Pennsylvania/Wistar Institute |
Phase II |
||
|
peginterferon alfa-2b |
Wistar Institute |
Phase II |
9th HIV Persistence |
|
|
raltegravir |
Canadian Immunodeficiency Research Collaborative |
Phase II |
||
|
raltegravir |
Fundación para la Investigación |
Phase II |
||
|
Viral suppression after analytic treatment interruption in Thai patients who initiated HAART during acute HIV infection |
South East Asia Research Collaboration with Hawaii |
Phase II |
Nat Med. 2018 Jun 11 CROI 2017, Abstract |
|
|
alpha interferon intensification |
NIAID |
Phase I/II |
N/A |
|
|
indinavir + zidovudine + lamivudine + nevirapine |
NIAID |
Phase I |
N/A |
|