Worldwide Research Towards a Cure Trials
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 clinicaltrials.gov 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. Table 3 contains completed studies, with links to published or presented results where available. Additional information on current approaches in HIV cure research can be found in TAG’s annual pipeline report and cure research fact sheet. Please send updates, corrections, or suggestions to Richard Jefferys at richard.jefferys@treatmentactiongroup.org.
February 28, 2017
Table 1. Current Clinical Trials
| Trial | Trial Registry Identifier(s) | Manufacturer/ Sponsor(s) |
Phase | Estimated Study Completion Date |
| ADOPTIVE IMMUNOTHERAPY | ||||
| Reconstitution of HIV-specific immunity against HIV | NCT02563509 | Guangzhou 8th People’s Hospital | Phase I/II | December 2016 |
| HXTC: HIV 1 antigen expanded specific T cell therapy | NCT02208167 | University of North Carolina, Chapel Hill | Phase I | September 2018 |
| ANTIBODIES | ||||
| VRC01 (broadly neutralizing monoclonal antibody) | NCT02664415 | National Institute of Allergy and Infectious Diseases (NIAID) | Phase II | July 2017 |
| 3BNC117 (broadly neutralizing monoclonal antibody) | NCT02446847 (closed to enrollment) |
Rockefeller University | Phase I/II | March 2018 |
| 3BNC117 | NCT02588586 (closed to enrollment) |
Rockefeller University | Phase I/II | March 2018 |
| 10-1074 (broadly neutralizing monoclonal antibody) | NCT02511990 (closed to enrollment) |
Rockefeller University | Phase I | July 2017 |
| 3BNC117 + 10-1074 | NCT02825797 | Rockefeller University | Phase I | June 2018 |
| PGT121 | NCT02960581 | International AIDS Vaccine Initiative | Phase I | March 2018 |
| vedolizumab (anti-α₄β₇ integrin antibody) | NCT02788175 | NIAID | Phase I | May 2020 |
| VRC01LS (long-acting broadly neutralizing monoclonal antibody) | NCT02840474 | NIAID | Phase I | August 2018 |
| VRC01 in acute HIV infection | NCT02591420 | NIAID | Phase I | December 2016 |
| VRC01 | NCT02471326 (closed to enrollment) |
NIAID | Phase I | June 2018 |
| ANTI-FIBROTIC | ||||
| losartan | NCT01852942 | University of Minnesota | Phase II | July 2018 |
| telmisartan | NCT02170246 | Yale University | Phase I | February 2019 |
| ANTI-INFLAMMATORY | ||||
| canakinumab (IL-1β inhibitor) | NCT02272946 | University of California, San Francisco | Phase II | June 2017 |
| CC-11050 (phosphodiesterase-4 inhibitor) | NCT02652546 | NIAID | Phase I | October 2017 |
| metformin | NCT02659306 | McGill University Health Center | Phase I | October 2017 |
| ANTIRETROVIRAL THERAPY | ||||
| dolutegravir in reservoirs | NCT02924389 | Emory University | Phase N/A | June 2020 |
| HIV reservoir dynamics after switching to dolutegravir in patients on a PI/r based regimen | NCT02513147 (closed to enrollment) |
Hospital Universitari Vall d’Hebron Research Institute | Phase IV | November 2016 |
| ABX464 | NCT02735863 | Abivax S.A. | Phase II | October 2016 |
| ANTIRETROVIRAL THERAPY IN HIV CONTROLLERS | ||||
| emtricitabine + rilpivirine + tenofovir | NCT01777997 (closed to enrollment) |
AIDS Clinical Trials Group/NIAID | Phase IV | May 2017 |
| COMBINATIONS | ||||
| Perturbing of HIV reservoir with immune stimulation: Fluarix, Pneumovax vaccines | NCT02707692 | University of California, San Diego | Not listed | January 2021 |
| Impact of Sirolimus and maraviroc on CCR5 expression and the HIV-1 reservoir in HIV+ kidney transplant recipients | NCT02990312 (not yet open for enrollment) |
University of Maryland | Phase IV | July 2020 |
| ROADMAP: romidepsin + 3BNC117 | NCT02850016 | Rockefeller University | Phase IIa | December 2018 |
| eCLEAR: romidepsin + 3BNC117 | NCT03041012 | Aarhus University Hospital | Phase II | August 2019 |
| panobinostat + pegylated interferon-alpha2a | NCT02471430 | Massachusetts General Hospital | Phase II | February 2020 |
| Research In Viral Eradication of HIV Reservoirs (RIVER): ART, ChAdV63.HIVconsv & MVA.HIVconsv vaccines, vorinostat | NCT02336074 UK CPMS18010 |
Imperial College London
|
Phase II | July 2018 |
| SB-728mR-T (autologous CD4 T cells genetically modified at the CCR5 gene) +cyclophosphamide | NCT02225665 (closed to enrollment) |
Sangamo BioSciences | Phase I/II | June 2018 |
| SB-728-T + cyclophosphamide | NCT01543152 (closed to enrollment) |
Sangamo BioSciences | Phase I/II | September 2016 |
| AGS-004 + vorinostat | NCT02707900 | NIAID | Phase I | December 2019 |
| DCV3 (dendritic cell-based vaccine pulsed with autologous inactivated HIV) + pegylated interferon | NCT02767193 (not yet open for enrollment) |
Judit Pich Martínez, Fundació Clínic per la Recerca Biomèdica | Phase I | June 2018 |
| MVA.HIVconsv + romidepsin | NCT02616874 (closed to enrollment) |
IrsiCaixa | Phase I | October 2017 |
| SB-728mR-T + cyclophosphamide | NCT02388594 | University of Pennsylvania | Phase I | March 2017 |
| CD4-ZETA gene-modified T cells +/- interleukin-2 (IL-2) | NCT01013415 (closed to enrollment) |
University of Pennsylvania | Phase I | June 2016 |
| GENE THERAPIES | ||||
| Cal-1: Dual anti-HIV gene transfer construct | ACTRN12615000763549 | Calimmune | Phase I/II | N/A |
| Cal-1: Dual anti-HIV gene transfer construct | NCT01734850 (closed to enrollment) NCT02390297 (long term safety phase) |
Calimmune | Phase I/II | June 2015 January 2032 |
| VRX496 (gene-modified autologous CD4 T cells) | NCT00295477 (closed to enrollment) |
University of Pennsylvania | Phase I/II | December 2020 |
| SB-728mR-HSPC (autologous hematopoietic stem/progenitor cells genetically modified at the CCR5 gene) | NCT02500849 | City of Hope Medical Center | Phase I | July 2018 |
| MazF-T (redirected MazF-CD4 autologous T cells) | NCT01787994 (closed to enrollment) |
Takara Bio/University of Pennsylvania | Phase I | December 2016 |
| C34-CXCR4 (autologous CD4 T cells gene-modified to express HIV-inhibiting C34 peptide) | NCT03020524 (not yet open for enrollment) |
University of Pennsylvania
|
Phase 0 | January 2018 |
| GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS | ||||
| Stem cells gene-modified with CCR5 shRNA/TRIM5alpha/TAR decoy | NCT02797470 | AIDS Malignancy Consortium | Phase I/II | September 2019 |
| Stem cells gene-modified with M87o vector encoding HIV-inhibiting C46 peptide | NCT00858793 (suspended) |
Universitätsklinikum Hamburg-Eppendorf | Phase I/II | October 2017 |
| Stem cells gene-modified with C46/CCR5/P140K | NCT02343666 | Fred Hutchinson Cancer Research Center | Phase I | August 2020 |
| Stem cells gene-modified with Cal-1 | NCT02378922 (suspended) |
Fred Hutchinson Cancer Research Center | Phase I | June 2019 |
| Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) | NCT02337985 | City of Hope Medical Center | Not listed | June 2031 |
| Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) + busulfan | NCT01961063 | City of Hope Medical Center | Not listed | October 2030 |
| Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) | NCT00569985 (closed to enrollment) |
City of Hope Medical Center | Not listed | December 2015 |
| IMAGING STUDIES | ||||
| Radiolabeled broadly neutralizing anti-HIV antibody 3BNC117 + Copper-64 radio isotope followed by MRI/PET scanning to detect HIV in vivo | NCT03063788 | Bayside Health | Phase I | December 2017 |
| IMMUNE CHECKPOINT INHIBITORS | ||||
| nivolumab (anti-PD-1 antibody) + ipilimumab(ant-CTLA-4 antibody) in treating patients with advanced HIV associated solid tumors | NCT02408861 | National Cancer Institute (NCI) | Phase I | December 2020 |
| pembrolizumab (anti-PD-1 antibody) in treating patients with HIV and relapsed, refractory, or disseminated malignant neoplasms | NCT02595866 | National Cancer Institute (NCI) | Phase I | April 2018 |
| JANUS KINASE INHIBITORS | ||||
| ruxolitinib | NCT02475655 | NIAID | Phase II | October 2016 |
| LATENCY-REVERSING AGENTS | ||||
| Chidamide | NCT02902185 | Tang-Du Hospital | Phase II/III | December 2018 |
| MGN1703 toll-like receptor 9 (TLR-9) agonist | NCT02443935 (enrolling by invitation only) |
University of Aarhus | Phase Ib/IIa | January 2017 |
| Poly-ICLC (TLR-3 agonist) | NCT02071095 (closed to enrollment) |
Nina Bhardwaj, MD/Campbell Foundation/Oncovir, Inc. | Phase I/II | June 2017 |
| romidepsin (HDAC inhibitor) | NCT01933594 | AIDS Clinical Trials Group/NIAID/Gilead | Phase I/II | August 2017 |
| GS-9620 (TLR-7 agonist) in ART-treated HIV controllers | NCT03060447 | Gilead Sciences | Phase Ib | September 2018 |
| GS-9620 (TLR-7 agonist) | NCT02858401 | Gilead Sciences | Phase Ib | December 2016 |
| ALT-803 (recombinant human super agonist interleukin-15 complex) | NCT02191098 | University of Minnesota – Clinical and Translational Science Institute | Phase I | June 2016 |
| Kansui (traditional Chinese medicine containing ingenols) | NCT02531295 (suspended pending additional animal studies) |
UCSF | Phase I | December 2019 |
| mTOR INHIBITORS | ||||
| Impact of Everolimus on HIV persistence post kidney or liver transplant | NCT02429869 | UCSF | Phase IV | June 2017 |
| Sirolimus | NCT02440789 | ACTG | Phase I/II | December 2016 |
| PROTEASOME INHIBITORS | ||||
| ixazomib | NCT02946047 (not yet open for enrollment) |
Nathan W. Cummins, M.D. | Phase I/II | September 2019 |
| STEM CELL TRANSPLANTATION | ||||
| HIVECT: HIV eradication through cord-blood transplantation | NCT02923076 | 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 underlying disease | NCT02140944 | IMPAACT/NIAID/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | N/A | N/A |
| BMT CTN 0903: Allogeneic transplant in individuals with chemotherapy-sensitive hematologic malignancies and coincident HIV infection | NCT01410344 (closed to enrollment) |
National Heart, Lung, and Blood Institute (NHLBI)/National Cancer Institute (NCI)/ Blood and Marrow Transplant Clinical Trials Network |
Phase II | November 2015 |
| Immune response after stem cell transplant in HIV-positive patients with hematologic cancer | NCT00968630 | Fred Hutchinson Cancer Research Center | Phase II | September 2017 |
| THERAPEUTIC VACCINES | ||||
| iHIVARNA-01 (TriMix & HIV antigen naked messenger RNA) | NCT02888756 (not yet open for enrollment) |
Rob Gruters, Erasmus Medical Center | Phase IIa | November 2017 |
| GTU-multiHIV + LIPO-5 (DNA + lipopeptide vaccines) | NCT01492985 (closed to enrollment) |
French National Institute for Health and Medical Research/French National Agency for Research on AIDS and Viral Hepatitis (Inserm/ANRS) | Phase II | October 2017 |
| GTU-MultiHIV B-clade + MVA HIV-B (DNA + viral vector vaccines) | NCT02972450 (not yet open for enrollment) |
Inserm/ANRS | Phase II | July 2018 |
| VAC-3S (peptide-based vaccine) | NCT02041247 (closed to enrollment) |
InnaVirVax | Phase II | November 2016 |
| VAC-3S | NCT02390466 (closed to enrollment) |
InnaVirVax | Phase I/IIa | April 2017 |
| Tat Oyi (protein-based vaccine) | NCT01793818 (closed to enrollment) |
Biosantech | Phase I/II | March 2016 |
| THV01 (lentiviral vector-based therapeutic vaccine) | NCT02054286 (closed to enrollment) |
Theravectys S.A. | Phase I/II | March 2019 |
| Ad26.Mos.HIV + MVA-Mosaic | NCT02919306 (closed to enrollment) |
Janssen Vaccines & Prevention B.V. | Phase I | May 2019 |
| Recombinant adenovirus type 5 vaccine | NCT02762045 | Centers for Disease Control and Prevention, China | Phase I | December 2017 |
| iHIVARNA-01 (TriMix & HIV antigen naked messenger RNA) | NCT02413645 (closed to enrollment) |
Biomedical Research Institute August Pi i Sunyer (IDIBAPS) | Phase I | October 2016 |
| HIVAX (lentiviral vector-based therapeutic vaccine) | NCT01428596 | GeneCure Biotechnologies | Phase I | December 2015 |
| MAG-pDNA + rVSVIN HIV-1 Gag (DNA + viral vector vaccines) | NCT01859325 (closed to enrollment) |
NIAID/Profectus Biosciences, Inc. | Phase I | November 2016 |
| TRADITIONAL CHINESE MEDICINE | ||||
| Triptolide wilfordii | NCT02219672 | Peking Union Medical College | Phase III | July 2017 |
| TREATMENT INTENSIFICATION/EARLY TREATMENT | ||||
| LEOPARD: Latency and early neonatal provision of antiretroviral drugs clinical trial | NCT02431975 | Columbia University | Not listed | July 2020 |
| New Era Study: Treatment with multi–drug class (MDC) HAART | NCT00908544 (closed to enrollment) |
MUC Research GmbH | Not listed | November 2019 |
| Antiretroviral regime for viral eradication in newborns | NCT02712801 | National Center for Women and Children’s Health, China CDC | Phase IV | December 2018 |
| DGVTRU: Immediate initiation of antiretroviral therapy during “hyperacute” HIV infection | NCT02656511 | UCSF | Phase IV | January 2018 |
| DIORR: Dolutegravir impact on residual replication | NCT02500446 (closed to enrollment) |
University of Melbourne | Phase IV | December 2016 |
| DRONE: Impact of starting a dolutegravir-based regimen on HIV-1 proviral DNA reservoir of treatment naïve and experienced patients | NCT02370979 | University Hospital, Strasbourg, France | Phase IV | July 2017 |
| AAHIV: Antiretroviral therapy for acute HIV infection | NCT00796263 | South East Asia Research Collaboration with Hawaii | Phase III | July 2019 |
| tenofovir/emtricitabine + dolutegravir ortenofovir/emtricitabine + darunavir/cobicistat | NCT02987530 (not yet open for enrollment) |
French National Agency for Research on AIDS and Viral Hepatitis (Inserm/ANRS) | Phase III | December 2019 |
| VIRECURE: Impact of extremely early ART to reduce viral reservoir & induce functional cure of HIV infection | NCT02588820 | David Garcia Cinca, Hospital Clinic of Barcelona | Phase III | May 2017 |
| EIT: Early infant HIV treatment in Botswana | NCT02369406 | Harvard School of Public Health | Phase II/III | February 2019 |
| EARLIER: Early ART to limit infection and establishment of reservoir | NCT02859558 | AIDS Clinical Trials Group | Phase II | December 2019 |
| peginterferon alfa-2b | NCT02227277 | The Wistar Institute | Phase II | January 2018 |
| peginterferon alfa-2b | NCT01935089 (closed to enrollment) |
University of Pennsylvania/Wistar Institute | Phase II | July 2016 |
| alpha interferon intensification | NCT01295515 (closed to enrollment) |
NIAID | Phase I/II | January 2020 |
| IMPAACT P1115: Very early intensive treatment of HIV-infected infants to achieve HIV remission | NCT02140255 | IMPAACT/NIAID/NICHD | Phase I/II | April 2022 |
Table 2. Observational Studies
| Trial | Trial Registry Identifier(s) | Manufacturer/ Sponsor(s) |
Phase | Estimated Study Completion Date |
| ACTG A5321: Decay of HIV-1 reservoirs in subjects on long-term antiretroviral therapy: The ACTG HIV reservoirs cohort (AHRC) study | Not listed yet, see ACTG website entry for information | AIDS Clinical Trials Group | N/A | N/A |
| Analytic treatment interruption (ATI) to assess HIV cure | NCT02437526 (enrolling by invitation only) |
Mayo Clinic | N/A | May 2020 |
| Biomarkers to predict time to plasma HIV RNA rebound | NCT03001128 (not yet open for enrollment) |
AIDS Clinical Trials Group | N/A | December 2020 |
| CLEAC: Comparison of late versus early antiretroviral therapy in HIV-infected children | NCT02674867 | French National Agency for Research on AIDS and Viral Hepatitis (Inserm/ANRS) | N/A | December 2018 |
| CODEX (the “Extreme” cohort) | NCT01520844 | Inserm/ANRS | N/A | February 2018 |
| Effects of dolutegravir based regimen on HIV-1 reservoir and immune activation | NCT02557997 | University Hospital, Strasbourg, France | N/A | September 2016 |
| EPIC4: Early Pediatric Initiation: Canada Child cure Cohort Study | CTN S 281 | Canadian Institutes of Health Research (CIHR)/Canadian Foundation for AIDS Research (CANFAR)/International AIDS Society (IAS) | N/A | December 2018 |
| Establish and characterize an acute HIV infection cohort in a high-risk population | NCT00796146 | Southeast Asia Research Collaboration with Hawaii/Armed Forces Research Institute of Medical Sciences/Thai Red Cross AIDS Research Centre | N/A | July 2019 |
| EURECA: Exploratory study of cellular reservoirs in blood | NCT02858414 | Centre Hospitalier Universitaire de Besancon | N/A | December 2016 |
| HEATHER: HIV reservoir targeting with early antiretroviral therapy | UK CPMS17589 (link currently broken) | University of Oxford/Medical Research Council/British HIV Association | N/A | September 2019 |
| HIV-STAR: HIV sequencing after treatment interruption to identify the clinically relevant anatomical reservoir | NCT02641756 (enrolling by invitation only) |
University Hospital, Ghent
|
N/A | December 2019 |
| Host & viral factors associated with HIV elite control | UK CPMS16146 (link currently broken) | University College London Hospitals NHS Foundation Trust | N/A | May 2021 |
| HSCT-HIV: Allogeneic hematopoietic stem cell transplantation in HIV-1 infected patients | NCT02732457 | Kirby Institute | N/A | September 2019 |
| ImmunoCo27: Co-adaptation between HIV and CD8 cellular immunity | NCT02886416 (not yet open for enrollment) |
French National Agency for Research on AIDS and Viral Hepatitis (Inserm/ANRS) | N/A | September 2018 |
| Impact of ART adherence on HIV persistence and inflammation | NCT02797093 | University of Colorado, Denver | N/A | September 2017 |
| ISALA: Analytical treatment interruption in HIV positive patients | NCT02590354 | Institute of Tropical Medicine, Belgium | N/A | November 2017 |
| LoViReT: Low viral reservoir treated patients | NCT02972931 | IrsiCaixa | N/A | December 2017 |
| Post analytic treatment interruption study | NCT02761200 (closed to enrollment) |
South East Asia Research Collaboration with Hawaii | N/A | June 2020 |
| Quantitative measurement and correlates of the latent HIV reservoir in virally suppressed Ugandans | NCT02154035 | NIAID | N/A | December 2019 |
| The use of leukapheresis to support HIV pathogenesis studies | NCT01161199 | University of California, San Francisco | N/A | July 2020 |
Table 3. Completed Studies
| Trial | Trial Registry Identifier(s) | Manufacturer/ Sponsor(s) |
Phase | Published/Presented Data |
| ADOPTIVE IMMUNOTHERAPY | ||||
| Early ART in combination with autologous HIV-specific cytotoxic T lymphocyte (CTL) infusion | NCT02231281 | Yongtao Sun, MD, PhD, Tangdu Hospital, the Fourth Military Medical University | Phase III | N/A |
| ANTIBODIES | ||||
| CHERUB 001 Intravenous immunoglobulin in primary HIV infection |
No clinicaltrials.gov entry | CHERUB (Collaborative HIV Eradication of viral Reservoirs: UK BRC) | N/A | CROI 2017, Abstract 324 |
| 3BNC117 | NCT02018510 | Rockefeller University | Phase I | Nature. 2015 Jun 25;522(7557):487-91 |
| VRC01 | NCT02411539 | NIAID | Phase I | N/A |
| VRC01 | NCT02463227 | NIAID | Phase I | N Engl J Med. 2016 Nov 24;375(21):2037-2050 CROI 2016, Abstract 32LB, Webcast |
| VRC01 | NCT01950325 | NIAID | Phase I | Sci Transl Med. 2015 Dec 23;7(319):319ra206 |
| ANTI-FIBROTIC | ||||
| ACE inhibitors | NCT01535235 | UCSF/amfAR | Phase IV | N/A |
| ANTIRETROVIRAL THERAPY | ||||
| raltegravir or efavirenz + tenofovir +emtricitibine | NCT00734344 | University of Alabama at Birmingham | Phase IV | N/A |
| ANTIRETROVIRAL THERAPY IN HIV CONTROLLERS | ||||
| raltegravir + tenofovir + emtricitabine | NCT01025427 | University of California, San Francisco | Phase IV | PLoS Pathog. 2013;9(10):e1003691 |
| ASSEMBLY INHIBITOR | ||||
| BIT225 | ACTRN12612000696897 | Biotron Limited | Phase I | J Antimicrob Chemother. 2016 Mar;71(3):731-8 |
| COMBINATIONS | ||||
| chemotherapy + maraviroc in people with non-Hodgkin lymphoma | NCT02486510 | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Phase 0 | Terminated due to futility criteria |
| ERAMUNE-01 (antiretroviral intensification +/- interleukin-7) |
NCT01019551 | ORVACS/Cytheris SA/Merck Sharp & Dohme Corp./Pfizer | Phase II | AIDS. 2016 Jan;30(2):221-30 |
| ERAMUNE-02
(DNA/Ad5 vaccine, ART intensification) |
NCT00976404 | Vical/GenVec/CHERUB/NIH Vaccine Research Center/ORVACS | Phase II | CROI 2014, Poster abstract 422 |
| Vacc-4x + romidepsin | NCT02092116 | Bionor Immuno AS/Celgene | Phase I/II | Lancet HIV 2016, July 7, 2016 |
| Vacc-4x (peptide-based therapeutic vaccine) + lenalidomide |
NCT01704781 | Bionor Immuno AS | Phase I/II | IAS 2015 Towards an HIV Cure Symposium,Poster Abstract PE61 |
| vorinostat + hydroxychloroquine + maraviroc (VHM) | NCT02475915 NCT02470351 (CNS substudy) |
South East Asia Research Collaboration with Hawaii | Phase I/II | AIDS 2016, Abstract TUAX0101LB |
| MVA-B (viral vector vaccine) +/- disulfiram | NCT01571466 | Hospital Clinic of Barcelona/HIVACAT | Phase I | J Antimicrob Chemother. 2015 Feb 26. pii: dkv046. PLoS One. 2015 Nov 6;10(11):e0141456. |
| GENE THERAPIES | ||||
| SB-728-T | NCT01252641 | Sangamo BioSciences | Phase I/II | N/A |
| SB-728-T | NCT01044654 | Sangamo BioSciences | Phase I | ICAAC 2014, Abstract H-643; 2013, Abstract H-1464c |
| SB-728-T | NCT00842634 | Sangamo Biosciences/University of Pennsylvania | Phase I | N Engl J Med. 2014 Mar 6;370(10):901–10 |
| Redirected high affinity Gag-specific T cells | NCT00991224 | University of Pennsylvania/Adaptimmune | Phase I | N/A |
| HGTV43 | No clinicaltrials.gov entry | Enzo Biochem | Phase I | AIDS 2006, Abstract MOPDA06 |
| IMMUNE CHECKPOINT INHIBITORS | ||||
| BMS-936559 (anti-PD-L1 antibody) | NCT02028403 | National Institute of Allergy and Infectious Diseases (NIAID) | Phase I | CROI 2016, Abstract 25, Webcast |
| IRON CHELATORS | ||||
| deferiprone | NCT02456558 | ApoPharma | Phase I | N/A |
| LATENCY-REVERSING AGENTS | ||||
| disulfiram | NCT01286259 | University of California, San Francisco/ Johns Hopkins University/amfAR |
Not specified | Clin Infect Dis. 2014 58 (6): 883–90 |
| vorinostat (HDAC inhibitor) | NCT01365065 | Bayside Health/Merck | Phase II | PLoS Pathog. 2014;10(10):e1004473 |
| valproic acid (HDAC inhibitor) | NCT00289952 | McGill University/Canadian Foundation for AIDS Research/CIHR Canadian HIV Trials Network | Phase II | HIV Med. 2012 May;13(5):291–6 |
| valproic acid | NCT00614458 | University of North Carolina at Chapel Hill/NIAID/Abbott/Merck Sharp & Dohme Corp. | Phase II
|
PLoS One. 2010 5(2): e9390 |
| Chidamide (HDAC inhibitor) | NCT02513901 | Tang-Du Hospital | Phase I/II | N/A |
| disulfiram (acetaldehyde dehydrogenase inhibitor) | NCT01944371 | University of California, San Francisco/Monash University/amfAR | Phase I/II | CROI 2015, Poster abstract 428LB |
| panobinostat (HDAC inhibitor) | NCT01680094 | University of Aarhus/ Massachusetts General Hospital/Monash University/Karolinska Institutet/Novartis/amfAR |
Phase I/II | The Lancet HIV. 2014 Oct; 1(1): e13–e21
CROI 2015, Abstract 109, Webcast |
| vorinostat | NCT01319383 | University of North Carolina at Chapel Hill/NIAID/Merck | Phase I/II | Nature. 2012 Jul 25;487(7408):482-5 J Infect Dis. 2014 Sep 1;210(5):728-35 |
| bryostatin 1 (PKC agonist) | NCT02269605 | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Phase I | AIDS. 2016 Feb 17. [Epub ahead of print] |
| OBSERVATIONAL STUDIES | ||||
| ANRS EP 44: Residual replication of HIV-1 in the gut associated lymphoid tissue (GALT) | NCT01038401 | French National Agency for Research on AIDS and Viral Hepatitis | N/A | N/A |
| CHERUB 003 (prospective HIV chemotherapy cohort study) |
NCT01902693 | Imperial College London/CHERUB | N/A | N/A
|
| HIV resistance and treatment strategies | NCT00581802 | NIAID | N/A | N/A |
| In vitro autologous vaccine development to activate HIV reservoirs | UK CPMS17532 (link currently broken) | Imperial College London/amfAR | N/A | N/A |
| MUCOVIR: Exploration of HIV reservoirs | NCT01019044 | Objectif Recherche Vaccins SIDA | N/A | JAIDS. 2013 Mar 1;62(3):255–9 |
| Size of the HIV-1 reservoir and ongoing replication in defined cohorts | UK CPMS16004 (link currently broken) | University College London/amfAR | N/A | N/A |
| Tat protein vaccine (roll-over observational study for extended follow-up of volunteers in the ISS T-003 trial) | NCT02712489 | Barbara Ensoli, MD, Istituto Superiore di Sanità/Italian Ministry of Foreign Affairs | N/A | N/A |
| Tissue drug levels of HIV medications | NCT01490346 | University of Minnesota – Clinical and Translational Science Institute/NIAID | N/A | Proc Natl Acad Sci USA. 2014 Feb 11;111(6):2307-12. |
| ULTRASTOP (Towards HIV Functional Cure)ERAMUNE-03 (antiretroviral treatment interruption) | NCT01876862 | Objectif Recherche VACcin Sida (ORVACS)/Fondation Bettencourt Schueller | N/A | AIDS, Published Ahead-of-Print, January 4, 2016 |
| VIRECT: Impact of pre-ART CD4 T cell level on the rectal reservoir in long-term HIV-1 treated men | NCT02526940 | Centre Hospitalier Universitaire de Saint Etienne | N/A | N/A |
| THERAPEUTIC VACCINES | ||||
| AGS-004 (personalized therapeutic vaccine utilizing patient-derived dendritic cells and HIV antigens) | NCT00672191 | Argos Therapeutics | Phase IIb | J Acquir Immune Defic Syndr. 2016 May 1;72(1):31-8 |
| AGS-004 | NCT01069809 | Argos Therapeutics | Phase IIb | IAS 2015 Towards an HIV Cure Symposium,Combination Therapy Trials Roundtable CROI 2014, Poster abstract 344 |
| DermaVir (topically applied DNA vaccine) | NCT00711230 | Genetic Immunity | Phase II | N/A |
| DermaVir | NCT00918840 | Genetic Immunity | Phase II
|
N/A |
| GSK Biologicals HIV Vaccine 732462 (p24-RT-Nef-p17 fusion protein vaccine) | NCT01218113 | GlaxoSmithKline | Phase II | Medicine (Baltimore). 2016 Feb;95(6):e2673 |
| Tat protein vaccine | NCT01513135 | Barbara Ensoli, MD, Istituto Superiore di Sanità/Italian Ministry of Foreign Affairs – General Direction for Cooperation and Development | Phase II | N/A |
| Tat protein vaccine | NCT01513135 | Barbara Ensoli, MD, Istituto Superiore di Sanità | Phase II | Retrovirology. 2015 Apr 29;12(1):33 PLoS One. 2010 Nov 11;5(11):e13540 |
| Vacc-4x (peptide-based vaccine) | NCT00659789 | Bionor Immuno AS | Phase II | Lancet Infect Dis. 2014 Apr;14(4):291-300 |
| VAC-3S (peptide-based vaccine) | NCT01549119 | InnaVirVax | Phase I/IIa | 30 Years of HIV Science, 2013, poster abstract 145 IAS 2015 Towards an HIV Cure Symposium,Poster Abstract PE67 LB |
| AGS-004 | NCT02042248 | University of North Carolina at Chapel Hill/Argos Therapeutics/U.S. National Institutes of Health (NIH) | Phase I/II | N/A |
| Autologous HIV-1 ApB DC Vaccine | NCT00510497 | Sharon Riddler, University of Pittsburgh/NIAID | Phase I/II | J Infect Dis. 2016 May 1;213(9):1400-9 |
| Dendritic cells pulsed with chemically inactivated HIV | NCT02766049 | University of Sao Paulo General Hospital | Phase I/II | J Int AIDS Soc. 2014 Jan 10;17:18938 J. Cellular Immunotherapy xx (2016) 1-10 |
| Dendritic cell vaccine | NCT00833781 | Massachusetts General Hospital | Phase I/II | N/A |
| Dendritic cell vaccine (DCV-2) | NCT00402142 | Hospital Clinic of Barcelona | Phase I/II | Sci Transl Med. 2013 Jan 2;5(166):166ra2 |
| DermaVir | NCT00270205 | AIDS Clinical Trials Group | Phase I/II | JAIDS. 2013 Dec 1;64(4):351–9 |
| GTU®-MultiHIV B Clade Vaccine | NCT02457689 | Imperial College London | Phase I/II | N/A |
| TUTI-16 (synthetic HIV-1 Tat epitope vaccine) | NCT01335191 | Thymon, LLC | Phase I/II | Hum Vaccin Immunother. 2012 Oct;8(10):1425-30 |
| Vacc-C5 (peptide-based vaccine) | NCT01627678 | Bionor Immuno AS | Phase I/II | N/A |
| ChAdV63.HIVcons + MVA.HIVconsv (viral vector vaccines) | NCT01712425 | IrsiCaixa/Fundació Lluita contra la SIDA/Hospital Clinic of Barcelona/ HIVACAT/University of Oxford | Phase I | IAS 2015, Poster abstract MOPEA036 |
| MVA.HIVconsv | NCT01024842 | University of Oxford/Medical Research Council | Phase I | N/A |
| D-GPE DNA + M-GPE MVA (DNA + viral vector vaccines) | NCT01881581 | Centers for Disease Control and Prevention, China | Phase I | N/A |
| JS7 DNA + MVA62B (DNA + viral vector vaccines) | NCT01378156 | GeoVax, Inc. | Phase I | HIV R4P 2014,Abstract OA05.03 (webcast) |
| MAG pDNA vaccine +/- IL-12 | NCT01266616 | NIAID | Phase I | N/A |
| AT20-KLH | MED-AT20-001 | Medestea Research & Production SpA, Turin | Phase I | Vaccine. 2014 Feb 19;32(9):1072-8 |
| AFO-18 (peptide-based vaccine) | NCT01141205 | Statens Serum Institut (SSI)/Ministry of the Interior and Health, Denmark/European and Developing Countries Clinical Trials Partnership (EDCTP) | Phase I | AIDS Res Hum Retroviruses. 2013 Nov;29(11):1504-12 |
| AFO-18 (peptide-based vaccine) | NCT01009762 | SSI/Rigshospitalet/Hvidovre University Hosp./Ministry of Interior & Health, Denmark | Phase I | Clin Immunol. 2013 Feb;146(2):120-30 |
| Dendritic cells loaded with HIV-1 lipopeptides | NCT00796770 | Baylor Research Institute/ANRS | Phase I | Retrovirology 2012, 9(Suppl 2):P328 |
| DermaVir | NCT00712530 | Genetic Immunity | Phase I | PLoS One. 2012 7(5): e35416 |
| HIV-v (peptide-based vaccine) | NCT01071031 | PepTcell Limited | Phase I | Vaccine. 2013 Nov 19;31(48):5680–6 |
| PENNVAX-B (Gag, Pol, Env) + electroporation | NCT01082692 | Inovio Pharmaceuticals | Phase I | Retrovirology 2012, 9(Suppl 2):P276 |
| PENNVAX-B +/- IL-12 or IL-15 | NCT00775424 | University of Pennsylvania | Phase I | N/A |
| TREATMENT INTENSIFICATION/EARLY TREATMENT | ||||
| Anti-HIV medications for people recently infected with HIV | NCT00106171 | NIAID | Phase IV | PLoS One. 2015 10(11):e0143259 |
| enfuvirtide | NCT00051831 | NIAID | Not listed | J Infect Dis. 2010 Jan 15;201(2):293–6 |
| enfuvirtide | NCT00334022 | Canadian Immunodeficiency Research Collaborative | Not listed | N/A |
| PLUS: Pilot study on the effect of adding raltegravir +/- a second drug on HIV levels in the gut | NCT00884793 | University of California, San Francisco | Not listed | J Infect Dis. 2010 Nov 15;202(10):1553–61
AIDS. 2010 Oct 23;24(16):2451–60 |
| ANRS 147 OPTIPRIM: Optimization of primary HIV-1 infection treatment | NCT01033760 | French National Institute for Health and Medical Research–French National Agency for Research on AIDS and Viral Hepatitis (Inserm–ANRS) | Phase III | PLoS One. 2013; 8(5): e64219.
PLoS One. 2013; 8(3): e59767 IAS 2013, Abstract WEAB0101 IAS Cure Symposium,Presentation |
| maraviroc | NCT00808002 | Germans Trias i Pujol Hospital | Phase III | AIDS. 2014 Jan 28;28(3):325–34 |
| raltegravir + maraviroc | NCT00935480 | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Phase III | N/A |
| raltegravir | NCT00554398 | Germans Trias i Pujol Hospital | Phase III | Antivir Ther. 2012;17(2):355–64 |
| Intense acute infection study | NCT01154673 | University of Toronto | Phase II/III | N/A |
| maraviroc | NCT00795444 | Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal/Pfizer | Phase II | PLoS One. 2011; 6(12):e27864 |
| raltegravir | NCT00520897 | Canadian Immunodeficiency Research Collaborative | Phase II | AIDS. 2012 Jan 14;26(2):167–74 |
| raltegravir | NCT00807443 | Fundación para la Investigación Biomédica del Hospital UniversitarioRamón y Cajal | Phase II | AIDS. 2012 Sep 24;26(15):1885–94 |
| Viral suppression after analytic treatment interruption in Thai patients who initiated HAART during acute HIV infection | NCT02614950 | South East Asia Research Collaboration with Hawaii | Phase II | CROI 2017, Abstract 124, Webcast |
| indinavir + zidovudine + lamivudine +nevirapine | NCT00001644 | NIAID | Phase I | N/A |
This article was originally published on Treatment Action Group on 1st December 2015 and re-published with permission.
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