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Research Toward 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. 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 and cure research fact sheet. Please send updates, corrections, or suggestions to Richard Jefferys at richard.jefferys@treatmentactiongroup.org.

August 17, 2018

Table 1. Current Clinical Trials

Trial

Trial Registry Identifier(s)

Manufacturer/
Sponsor(s)

Phase

Estimated End Date/Interim Results

ADOPTIVE IMMUNOTHERAPY

HST-NEETs: HIV-1 specific T-cells for HIV-infected individuals

NCT03485963

Children's Research Institute

Phase I

December 2021

ANTIBODIES

vedolizumab (anti-αβ integrin antibody)

NCT03577782

Hospitales Universitarios Virgen del Rocío

Phase II

May 2020

vedolizumab

NCT03147859

Ottawa Hospital Research Institute

Phase II

December 2018

VRC01 (broadly neutralizing antibody) in infants

NCT03208231

NIAID

Phase I/II

January 2020

3BNC117 + 10-1074 (broadly neutralizing antibodies)

NCT03571204

Rockefeller University

Phase I

June 2022

10-1074-LS + 3BNC117-LS (long-acting broadly neutralizing antibodies)

NCT03554408

Rockefeller University

Phase I

June 2020

3BNC117 + 10-1074

NCT03526848

Rockefeller University

Phase I

May 2020

3BNC117 + 10-1074

NCT02825797

Rockefeller University

Phase I

June 2018

3BNC117-LS (long-acting broadly neutralizing antibody)

NCT03254277

Rockefeller University

Phase I

October 2019

AAV8-VRC07 (broadly neutralizing antibody delivered by AAV vector)

NCT03374202

NIAID

 

Phase I

March 2019

PGDM1400 +/- PGT121 (broadly neutralizing antibodies)

NCT03205917

International AIDS Vaccine Initiative

Phase I

July 2019

PGT121

NCT02960581
(enrolling by invitation only)

International AIDS Vaccine Initiative

Phase I

March 2018

VRC01LS (long-acting broadly neutralizing antibody)

NCT02840474

NIAID

Phase I

August 2018

VRC01 in acute HIV infection

NCT02591420

NIAID

Phase I

April 2018

ANTI-FIBROTIC

losartan

NCT01852942
(closed to enrollment)

University of Minnesota

Phase II

July 2018

telmisartan

NCT02170246

Yale University

Phase I

February 2019

ANTI-INFLAMMATORY

canakinumab (IL-1β inhibitor)

NCT02272946
(closed to enrollment)

University of California, San Francisco

Phase II

June 2020
CROI 2017,
Abstract 126, Webcast

High dose vitamin D supplementation

NCT03426592
(closed to enrollment)

University of Melbourne

Phase II

July 2019

ANTI-PROLIFERATIVE

mycophenolate mofetil (MMF)

NCT03262441

Fred Hutchinson Cancer Research Center

Phase I

August 2020

ANTIRETROVIRAL THERAPY

ABX464

NCT02990325

Abivax S.A.

Phase I/II

December 2018

CANNABINOIDS

 

 

 

 

TN-CT11LM, TN-TC19LM oral capsules

NCT03550352
(not yet open for enrollment)

McGill University Health Center

Phase II

December 2019

COMBINATIONS                                                                                                   

maraviroc, dolutegravir, dendritic cell vaccine, auranofin, nicotinamide

NCT02961829
(closed to enrollment)

Federal University of São Paulo

Not listed

March 2019
AIDS 2018, Abstract WEPDB0105 (
slides, video)

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

University of Maryland

Phase IV

July 2020

ROADMAP: romidepsin + 3BNC117

NCT02850016

Rockefeller University

Phase IIa

December 2018

Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2

NCT03346499

University of Minnesota - Clinical and Translational Science Institute

Phase II

January 2019

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
(closed to enrollment)

Imperial College London

 

Phase II

November 2022
AIDS 2018, Abstract TUAA0202LB (
slides, video)

iHIVARNA, MVA vector HIV vaccine, 10-1074, romidepsin, HIVACAR01 (personalized HIV RNA vaccine)

NCT03619278
(not yet open for enrollment)

David Garcia Cinca

Phase I/IIa

July 2020

disulfiram + vorinostat

NCT03198559
(suspended for review of adverse events)

The Peter Doherty Institute for Infection and Immunity

Phase I/II

July 2027

GTU-MultiHIV B-clade + MVA HIV-B +/- vedolizumab (DNA + viral vector vaccines +/- anti-αβ integrin antibody)

NCT02972450
(not yet open for enrollment)

Inserm-ANRS

Phase I/II

December 2021

CD4-ZETA gene-modified T cells +/- interleukin-2 (IL-2)

NCT01013415
(closed to enrollment)

University of Pennsylvania

Phase I

July 2021
Mol Ther. 2002 Jun;5(6):788-97

DCV3 (dendritic cell-based vaccine pulsed with autologous inactivated HIV) + pegylated interferon

NCT02767193

Judit Pich Martínez, Fundació Clínic per la Recerca Biomèdica

Phase I

November 2018

peginterferon alfa-2b + 3BNC117 + 10-1074

NCT03588715
(not yet open for enrollment)

Wistar Institute

Phase I

July 2020

SB-728mR-T + cyclophosphamide

NCT02388594
(closed to enrollment)

University of Pennsylvania

Phase I

January 2019

vorinostat + HXTC: HIV 1 antigen expanded specific T cell therapy

NCT03212989

Julia Sung, MD, University of North Carolina, Chapel Hill

Phase I

June 2021

vorinostat +/- tamoxifen in postmenopausal women

NCT03382834

NIAID

Phase I

November 2019

CYTOKINES

interleukin-2 (IL2)

NCT03308786
(not yet open for enrollment)

Case Western Reserve University

Phase II

December 2018

ALT-803 (recombinant human super agonist interleukin-15 complex)

NCT02191098

University of Minnesota - Clinical and Translational Science Institute

Phase I

July 2018
CROI 2018,
Poster abstract 356

DUAL-AFFINITY RE-TARGETING (DART) MOLECULES

MGD014

NCT03570918
(not yet open for enrollment)

MacroGenics

Phase I

March 2020

GENE THERAPIES

Cal-1: Dual anti-HIV gene transfer construct

NCT02390297 (long term safety phase, invitation only)

Calimmune

Phase I/II

January 2032

VRX496 (gene-modified autologous CD4 T cells)

NCT00295477
(closed to enrollment)

University of Pennsylvania

Phase I/II

December 2020
Blood. 2013 Feb 28; 121(9): 1524–1533

C34-CXCR4 (autologous CD4 T cells gene-modified to express HIV-inhibiting C34 peptide)

NCT03020524

University of Pennsylvania

 

Phase I

December 2019

CD4 CAR + C34-CXCR4 + SB-728mR modified T cells

NCT03617198
(not yet open for enrollment)

University of Pennsylvania

Phase I

December 2025

Chimeric Antigen Receptor (CAR)-T cell therapy

NCT03240328

Guangzhou 8th People's Hospital

Phase I

December 2018

MazF-T (redirected MazF-CD4 autologous T cells)

NCT01787994
(closed to enrollment)

Takara Bio/University of Pennsylvania

Phase I

December 2017

SB-728mR-HSPC (autologous hematopoietic stem/progenitor cells genetically modified at the CCR5 gene)

NCT02500849

City of Hope Medical Center

Phase I

July 2018

shRNA-modified CD34+ cells

NCT03517631

Shanghai Public Health Clinical Center

Phase I

January 2020

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

Stem cells gene-modified with Cal-1

NCT03593187
(not yet open for enrollment)

Assistance Publique - Hôpitaux de Paris

Phase I/II

June 2023

Stem cells gene-modified with CCR5 shRNA/TRIM5alpha/TAR decoy

NCT02797470

AIDS Malignancy Consortium

Phase I/II

September 2019

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

CRISPR CCR5 modified CD34+ cells

NCT03164135

307 Hospital of PLA (Affiliated Hospital of Academy to Military Medical Sciences)

Not listed

May 2021

Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ)

NCT02337985
(closed to enrollment)

City of Hope Medical Center

Phase I

June 2031

Stem cells gene-modified to encode multiple anti-HIV RNAs (rHIV7-shI-TAR-CCR5RZ) + busulfan

NCT01961063
(closed to enrollment)

City of Hope Medical Center

Phase I

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

Phase I

July 2018

GONADOTROPIN-RELEASING HORMONE (GnRH) AGONISTS

triptorelin acetate depot

NCT03536234

Immune System Regulation AB

Phase II

May 2019

HORMONES

somatotropin (human growth hormone)

NCT03091374

McGill University Health Center

Phase II

June 2019

IMAGING STUDIES

123I radiolabeled 3BNC117

NCT03468582

University of Lausanne Hospitals

Phase I

February 2019

Radiolabeled 3BNC117 + Copper-64 radio isotope followed by MRI/PET scanning to detect HIV in vivo

NCT03063788
(not yet open for enrollment)

Bayside Health

Phase I

February 2019

IMMUNE CHECKPOINT INHIBITORS

durvalumab (anti-PD-L1 antibody) in solid tumors

NCT03094286

Spanish Lung Cancer Group

Phase II

April 2022

nivolumab (anti-PD-1 antibody) + ipilimumab (anti-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
CROI 2018,
Poster abstract 656LB

pembrolizumab (anti-PD-1 antibody) single dose

NCT03239899

National Institute of Neurological Disorders and Stroke (NINDS)

Phase I

December 2020

LATENCY-REVERSING AGENTS

Chidamide

NCT02902185
(closed to enrollment)

Tang-Du Hospital

Phase II/III

December 2018

valproic acid + pyrimethamine

NCT03525730

Erasmus Medical Center

Phase I/II

April 2020

Kansui (traditional Chinese medicine containing ingenols)

NCT02531295
(not yet open for enrollment)

UCSF

Phase I

December 2019

mTOR INHIBITORS

Impact of Everolimus on HIV persistence post kidney or liver transplant

NCT02429869
(closed to enrollment)

UCSF

Phase IV

January 2018

metformin

NCT02659306
(closed to enrollment)

McGill University Health Center

Phase I

December 2018

PROTEASOME INHIBITORS

ixazomib

NCT02946047

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

International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)

N/A

March 2023

BMT CTN 0903: Allogeneic transplant in individuals with chemotherapy-sensitive hematologic malignancies and coincident HIV infection

NCT01410344
(closed to enrollment)

National Heart, Lung, & Blood Institute/National Cancer Institute/Blood & Marrow Transplant Clinical Trials Network

Phase II

December 2018

Maraviroc in HIV-1+ individuals requiring allogeneic hematopoietic cell transplant

NCT03118661

Washington University School of Medicine

Phase I

May 2025

THERAPEUTIC VACCINES

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

April 2018

p24CE1/2 + p55^gag conserved-element DNA vaccines

NCT03560258
(not yet open for enrollment)

NIAID

Phase I/II

April 2020

PENNVAX-GP or INO-6145 + IL-12 DNA adjuvant (INO-9012)

NCT03606213

Steven Deeks, UCSF

Phase I/II

December 2020

THV01 (lentiviral vector-based therapeutic vaccine)

NCT02054286
(closed to enrollment)

Theravectys S.A.

Phase I/II

March 2019

Ad26.Mos4.HIV + MVA-Mosaic or clade C gp140 + mosaic gp140

NCT03307915

Janssen Vaccines & Prevention B.V.

Phase I

February 2020

Ad26.Mos.HIV + MVA-Mosaic

NCT02919306
(closed to enrollment)

Janssen Vaccines & Prevention B.V.

Phase I

May 2019

DNA.HTI + MVA.HTI

NCT03204617

Aelix Therapeutics

Phase I

May 2018

MAG-pDNA + rVSVIN HIV-1 Gag (DNA + viral vector vaccines)

NCT01859325
(closed to enrollment)

NIAID/Profectus Biosciences, Inc.

Phase I

August 2019
Sci Transl Med. 2017 Dec 6;9(419). pii: eaan8848

TOLL-LIKE RECEPTOR AGONISTS

vesatolimod (TLR-7 agonist) in ART-treated HIV controllers

NCT03060447

Gilead Sciences

Phase Ib

September 2018

vesatolimod (formerly GS-9620) (TLR-7 agonist)

NCT02858401
(closed to enrollment)

Gilead Sciences

Phase Ib

November 2019

TREATMENT INTENSIFICATION/EARLY TREATMENT

LEOPARD: Latency and early neonatal provision of antiretroviral drugs clinical trial

NCT02431975

Columbia University

Not listed

July 2020

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

April 2020

AAHIV/RV254: Antiretroviral therapy for acute HIV infection

NCT00796263

South East Asia Research Collaboration with Hawaii

Phase III

July 2019
Multiple published studies (follow link for PubMed search results related to RV254/SEARCH 010)

tenofovir/emtricitabine + dolutegravir or tenofovir/emtricitabine + darunavir/cobicistat

NCT02987530

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

November 2018

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
(closed to enrollment)

The Wistar Institute

Phase II

August 2018

IMPAACT P1115: Very early intensive treatment of HIV-infected infants to achieve HIV remission

NCT02140255

IMPAACT

Phase I/II

December 2023

 

Table 2. Observational Studies

Trial

Trial Registry Identifier(s)

Manufacturer/
Sponsor(s)

Phase

Estimated End Date

Accurate staging of immuno-virological dynamics during acute HIV infection (ACS)

NCT03449706

University Hospital, Ghent

N/A

January 2023

Analytic treatment interruption (ATI) to assess HIV cure

NCT02437526
(enrolling by invitation only)

Mayo Clinic

N/A

May 2020

ANRS CO24 OncoVIHAC: Immune checkpoint inhibitors in HIV+ individuals with cancers

NCT03354936

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

NCT03298360

Inserm-ANRS

N/A

September 2019

APACHE: Monitored antiretroviral pause in chronically infected HIV+ individuals with long-lasting suppressed viremia

NCT03198325

Ospedale San Raffaele

N/A

April 2018

Biomarkers to predict time to plasma HIV RNA rebound

NCT03001128

AIDS Clinical Trials Group

N/A

December 2020

CLEAC: Comparison of late versus early antiretroviral therapy in HIV-infected children

NCT02674867

Inserm-ANRS

N/A

December 2018

CODEX (the Extreme cohort)

NCT01520844

Inserm-ANRS

N/A

September 2019

Developing a functional cure for HIV disease: Clinical specimen collection from HIV+ individuals

NCT03215004

American Gene Technologies International Inc.

N/A

July 2018

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 2018

FXReservoir: Study of the effects of farnesoid X receptor (FXR) ligands on the reactivation of latent provirus

NCT03618862
(not yet open for enrollment)

Hospices Civils de Lyon

N/A

December 2019

Genotyping FcɣRs genes

NCT03130296

University Hospital, Strasbourg, France

N/A

April 2020

HCURE: Analysis of the impact of HCV treatment by last generation direct antiviral agents (DAA) on antiviral Immunity and HIV DNA reservoir in coinfected HIV-HCV patients

NCT03244371

Assistance Publique Hopitaux De Marseille

N/A

February 2019

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

HIV-STAR: HIV sequencing after treatment interruption to identify the clinically relevant anatomical reservoir

NCT02641756
(closed to enrollment)

University Hospital, Ghent

 

N/A

December 2019

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 stem cell transplantation in HIV-1 infected patients

NCT02732457

Kirby Institute

N/A

September 2019

Identification and quantification of HIV CNS latency biomarkers

NCT02989285

St Vincent's Hospital, Sydney

 

N/A

December 2020

ImmunoCo27: Co-adaptation between HIV and CD8 cellular immunity

NCT02886416

Inserm-ANRS

N/A

September 2018

IMPAACT 2015: Evaluation of the HIV-1 reservoir in the CNS of perinatally-infected youth and young adults with cognitive impairment

NCT03416790
(not yet open for enrollment)

IMPAACT

N/A

January 2019

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

March 2019

LoViReT: Low viral reservoir treated patients

NCT02972931

IrsiCaixa

N/A

April 2019

Post analytic treatment interruption study

NCT02761200

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
(closed to enrollment)

NIAID

N/A

December 2019

Role of the IL-33/amphiregulin pathway as a potential therapeutic target in HIV infection

NCT03622177

Inserm-ANRS

N/A

September 2023

Specimen repository for HIV immunopathogenesis

NCT03579381

AIDS Healthcare Foundation

N/A

December 2020

TESOVIR: Tracking and exploring the source of viral rebound (ART interruption)

NCT03117985

Centre Hospitalier Régional d'Orléans

N/A

August 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

Reconstitution of HIV-specific immunity against HIV

NCT02563509

Guangzhou 8th People's Hospital

Phase I/II

N/A

HXTC: HIV 1 antigen expanded specific T cell therapy

NCT02208167

University of North Carolina, Chapel Hill

Phase I

IAS HIV Cure and Cancer Forum 2017, Abstract 24

ANTIBODIES

CHERUB 001
Intravenous immunoglobulin in primary HIV infection

No clinicaltrials.gov entry

CHERUB (Collaborative HIV Eradication of viral Reservoirs: UK BRC)

N/A

HIV Med. 2017 Jul 18. doi: 10.1111/hiv.12524.

3BNC117 (broadly neutralizing monoclonal antibody)

NCT02446847
(closed to enrollment)

Rockefeller University

Phase II

Nature. 2016 Jul 28; 535(7613):556–560

3BNC117

NCT02588586

Rockefeller University

Phase II

N/A

VRC01 (broadly neutralizing monoclonal antibody)

NCT02664415
(also entered in clinicaltrials.gov as NCT03036709)

National Institute of Allergy and Infectious Diseases (NIAID)

Phase II

IAS 2017, Abstract TUAB0106LB (slides, video)

10-1074 (broadly neutralizing monoclonal antibody)

NCT02511990

Rockefeller University

Phase I

Nat Med. 2017 Feb;23(2):185-191

3BNC117

NCT02018510

Rockefeller University

Phase I

Nature. 2015 Jun 25;522(7557):487-91

vedolizumab

NCT02788175

NIAID

Phase I

AIDS 2018, WESS0102

VRC01

NCT02411539

NIAID

Phase I

N/A

VRC01

NCT02471326

NIAID

Phase I

N Engl J Med. 2016 Nov 24;375(21):2037-2050

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

Pathogens and Immunity. 2017;2(3):310-34.

ANTI-INFLAMMATORY

CC-11050 (phosphodiesterase-4 inhibitor)

NCT02652546

NIAID

Phase I

N/A

ANTIRETROVIRAL THERAPY

dolutegravir in reservoirs

NCT02924389

Emory University

Phase N/A

AIDS. 2018 Jul 12 [Epub ahead of print]

HIV reservoir dynamics after switching to dolutegravir in patients on a PI/r based regimen

NCT02513147

Hospital Universitari Vall d'Hebron Research Institute

Phase IV

N/A

raltegravir or efavirenz + tenofovir + emtricitibine

NCT00734344

University of Alabama at Birmingham

Phase IV

N/A

ABX464

NCT02735863

Abivax S.A.

Phase II

N/A

ANTIRETROVIRAL THERAPY IN HIV CONTROLLERS

emtricitabine + rilpivirine + tenofovir

NCT01777997

AIDS Clinical Trials Group/NIAID

Phase IV

CROI 2018, Poster abstract 229

raltegravir + tenofovir + emtricitabine

NCT01025427

University of California, San Francisco

Phase IV

PLoS Pathog. 2013;9(10): e1003691

ASSEMBLY INHIBITORS

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

SB-728mR-T (autologous CD4 T cells genetically modified at the CCR5 gene) + cyclophosphamide

NCT02225665

Sangamo BioSciences

Phase I/II

N/A

SB-728-T + cyclophosphamide

NCT01543152

Sangamo BioSciences

Phase I/II

 

CROI 2014, Abstract 141, Webcast

CROI 2015, Poster abstract 434
CROI 2016, Poster abstract 358LB

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

AGS-004 + vorinostat

NCT02707900

NIAID

Phase I

Terminated (Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided.)

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.

MVA.HIVconsv + romidepsin

NCT02616874

IrsiCaixa

Phase I

CROI 2017, Abstract 119LB, Webcast

GENE THERAPIES

Cal-1: Dual anti-HIV gene transfer construct

NCT01734850

Calimmune

Phase I/II

N/A
 

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

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

Stem cells gene-modified with M87o vector encoding HIV-inhibiting C46 peptide

NCT00858793

Universitätsklinikum Hamburg-Eppendorf

Phase I/II

N/A

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
J Infect Dis. 2017 Jun 1;215(11):1725-1733

ipilimumab (anti-CTLA-4 antibody)

NCT03407105

Medarex

Phase I

PLoS One. 2018 Jun 7;13(6):e0198158

IRON CHELATORS

deferiprone

NCT02456558

ApoPharma

Phase I

N/A

JANUS KINASE INHIBITORS

ruxolitinib

NCT02475655

NIAID

Phase II

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

Phase II

 

PLoS One. 2010 5(2): e9390

Chidamide (HDAC inhibitor)

NCT02513901

Tang-Du Hospital

Phase I/II

AIDS 2018, Abstract WEAA0101 (slides, video)

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

romidepsin (HDAC inhibitor)

NCT01933594

AIDS Clinical Trials Group/NIAID/Gilead

Phase I/II

CROI 2018, Abstract 72, 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

J Clin Invest. 2017 Aug 1;127(8):3126-3135.

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]

mTOR INHIBITORS

Sirolimus

NCT02440789

ACTG

Phase I/II

N/A

OBSERVATIONAL STUDIES

ACTG A5321: Decay of HIV-1 reservoirs in subjects on long-term antiretroviral therapy: The ACTG HIV reservoirs cohort (AHRC) study

N/A

AIDS Clinical Trials Group

N/A

PLoS Pathog. 2017 Apr; 13(4): e1006285

ANRS EP 44: Residual replication of HIV-1 in the gut associated lymphoid tissue (GALT)

NCT01038401

Inserm-ANRS

N/A

N/A

CHERUB 003
(prospective HIV chemotherapy cohort study)

NCT01902693

Imperial College London/CHERUB

N/A

N/A

Effects of dolutegravir based regimen on HIV-1 reservoir and immune activation

NCT02557997

University Hospital, Strasbourg, France

N/A

J Antimicrob Chemother. 2017 Dec 13.

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

ISALA: Analytical treatment interruption in HIV positive patients

NCT02590354

Institute of Tropical Medicine, Belgium

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

STEM CELL TRANSPLANTATION

Immune response after stem cell transplant in HIV-positive patients with hematologic cancer

NCT00968630

Fred Hutchinson Cancer Research Center

Phase II

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
AIDS Res Hum Retroviruses. 2018 Jan;34(1):111-122

iHIVARNA-01 (TriMix & HIV antigen naked messenger RNA)

NCT02888756

Rob Gruters, Erasmus Medical Center

Phase IIa

Study terminated (interim analysis did not show sufficient immunogenicity compared to placebo)

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)

NCT02041247

InnaVirVax

Phase II

IAS 2017, Abstract MOSY0404 (slides, video)

VAC-3S

NCT02390466

InnaVirVax

Phase I/IIa

N/A

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

Tat Oyi (protein-based vaccine)

NCT01793818

Biosantech

Phase I/II

Retrovirology. 2016 Apr 1;13:21

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

BMC Infect Dis. 2017 Mar 24;17(1):228.
JAIDS April 2018;77:57

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

AT20-KLH

MED-AT20-001

Medestea Research & Production SpA, Turin

Phase I

Vaccine. 2014 Feb 19;32(9):1072-8

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

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

D-GPE DNA + M-GPE MVA (DNA + viral vector vaccines)

NCT01881581

Centers for Disease Control and Prevention, China

Phase I

N/A

HIVAX (lentiviral vector-based therapeutic vaccine)

NCT01428596

GeneCure Biotechnologies

Phase I

Vaccine. 2016 Apr 27;34(19):2225-32

HIV-v (peptide-based vaccine)

NCT01071031

PepTcell Limited

Phase I

Vaccine. 2013 Nov 19;31(48):5680–6

iHIVARNA-01 (TriMix & HIV antigen naked messenger RNA)

NCT02413645

Biomedical Research Institute August Pi i Sunyer (IDIBAPS)

Phase I

N/A

JS7 DNA + MVA62B (DNA + viral vector vaccines)

NCT01378156

GeoVax, Inc.

Phase I

PLoS One. 2016 Oct 6;11(10):e0163164

MAG pDNA vaccine +/- IL-12

NCT01266616

NIAID

Phase I

N/A

MVA.HIVconsv

NCT01024842

University of Oxford/Medical Research Council

Phase I

N/A

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

Recombinant adenovirus type 5 vaccine

NCT02762045

Centers for Disease Control and Prevention, China

Phase I

N/A

rMVA-HIV + rFPV-HIV (viral vector vaccines) in young adults

NCT00107549

NIAID

Phase I

AIDS. 2011 Nov 28; 25(18): 2227–2234

TOLL-LIKE RECEPTOR AGONISTS

MGN1703 toll-like receptor 9 (TLR-9) agonist

NCT02443935

University of Aarhus

Phase Ib/IIa

Clin Infect Dis. 2017 Mar 9

Poly-ICLC (TLR-3 agonist)

NCT02071095

Nina Bhardwaj, MD/Campbell Foundation/Oncovir, Inc.

Phase I/II

Clinicaltrials.gov study results page

TRADITIONAL CHINESE MEDICINE

Triptolide wilfordii

NCT02219672

Peking Union Medical College

Phase III

N/A

TREATMENT INTENSIFICATION/EARLY TREATMENT

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

New Era Study: Treatment with multidrug class (MDC) HAART

NCT00908544

MUC Research GmbH

Not listed

Front Immunol. 2018 Apr 30;9:811

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

Anti-HIV medications for people recently infected with HIV

NCT00106171

NIAID

Phase IV

PLoS One. 2015 10(11):e0143259

DIORR: Dolutegravir impact on residual replication

NCT02500446

University of Melbourne

Phase IV

CROI 2018, Abstract 71, Webcast

The Lancet HIV, Online First, April 8, 2018

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

N/A

ANRS 147 OPTIPRIM: Optimization of primary HIV-1 infection treatment

NCT01033760

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

peginterferon alfa-2a (Pegasys)

NCT00594880

Wistar Institute

Phase II

J Infect Dis. 2013 Jan 15; 207(2): 213–222

peginterferon alfa-2b

NCT01935089

University of Pennsylvania/Wistar Institute

Phase II

CROI 2017, Abstract 326

maraviroc

NCT00795444

Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal/Pfizer

Phase II

PLoS One. 2011; 6(12):e27864

AIDS. 2013 Aug 24; 27(13):2081-8.

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 Universitario Ramón 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
Nat Med. 2018 Jun 11 [Epub ahead of print]

alpha interferon intensification

NCT01295515

NIAID

Phase I/II

N/A

indinavir + zidovudine + lamivudine + nevirapine

NCT00001644

NIAID

Phase I

N/A