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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.

November 10, 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 2017

HXTC: HIV 1 antigen expanded specific T cell therapy

NCT02208167
(closed to enrollment)

University of North Carolina, Chapel Hill

Phase I

December 2017

ANTIBODIES

vedolizumab (anti-αβ integrin antibody)

NCT03147859
 

Ottawa Hospital Research Institute

Phase II

December 2018

VRC01 in acute HIV infection

NCT03036709

Nittaya Phanuphak, MD, PhD

Phase II

June 2018

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

VRC01 in infants

NCT03208231
(not yet open for enrollment)

NIAID

 

Phase I/II

January 2020

10-1074 (broadly neutralizing monoclonal antibody)

NCT02511990
(closed to enrollment)

Rockefeller University

Phase I

December 2017

3BNC117-LS

NCT03254277

Rockefeller University

Phase I

October 2019

3BNC117 + 10-1074

NCT02825797

Rockefeller University

Phase I

June 2018

PGDM1400 +/- PGT121

NCT03205917
(not yet open for enrollment)

International AIDS Vaccine Initiative

Phase I

July 2019

PGT121

NCT02960581
(enrolling by invitation only)

International AIDS Vaccine Initiative

Phase I

March 2018

vedolizumab (anti-αβ 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

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

University of California, San Francisco

Phase II

June 2018

ANTI-PROLIFERATIVE

mycophenolate mofetil (MMF)

NCT03262441

Fred Hutchinson Cancer Research Center

Phase I

August 2020

ANTIRETROVIRAL THERAPY

dolutegravir in reservoirs

NCT02924389

Emory University

Phase N/A

June 2020

ABX464

NCT02990325

Abivax S.A.

Phase I/II

March 2018

COMBINATIONS                                                                                                   

maraviroc, dolutegravir, dendritic cell vaccine, auranofin, nicotinamide

NCT02961829
(closed to enrollment)

Federal University of São Paulo

Not listed

March 2019

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

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

July 2018

disulfiram + vorinostat

NCT03198559
(suspended for review of adverse events)

The Peter Doherty Institute for Infection and Immunity

Phase I/II

July 2027

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

AGS-004 + vorinostat

NCT02707900

NIAID

Phase I

December 2019

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

NCT01013415
(closed to enrollment)

University of Pennsylvania

Phase I

July 2021

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

NCT02767193

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
(closed to enrollment)

University of Pennsylvania

Phase I

December 2018

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

NCT03212989

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

Phase I

June 2021

CYTOKINES

interleukin-2 (IL2)

NCT03308786
(not yet open for enrollment)

Case Western Reserve University

Phase II

December 2018

GENE THERAPIES

Cal-1: Dual anti-HIV gene transfer construct

NCT01734850
(closed to enrollment)
NCT02390297 (long term safety phase)

Calimmune

Phase I/II

October 2017
January 2032

VRX496 (gene-modified autologous CD4 T cells)

NCT00295477
(closed to enrollment)

University of Pennsylvania

Phase I/II

December 2020

Chimeric Antigen Receptor (CAR)-T cell therapy

NCT03240328
(not yet open for enrollment)

Guangzhou 8th People's Hospital

Phase I

December 2018

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 2017

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

NCT03020524

University of Pennsylvania

 

Phase I

January 2018

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

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

NCT02797470
(temporarily suspended due to manufacturing issues)

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 20, 2021

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
(closed to enrollment)

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

July 2018

HORMONES

somatotropin (human growth hormone)

NCT03091374

McGill University Health Center

Phase II

June 2019

IMAGING STUDIES

Radiolabeled broadly neutralizing anti-HIV antibody 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

December 2017

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 (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

pembrolizumab (anti-PD-1 antibody) single dose

NCT03239899

National Institute of Neurological Disorders and Stroke (NINDS)

Phase I

December 2020

JANUS KINASE INHIBITORS

ruxolitinib

NCT02475655

NIAID

Phase II

February 2018

LATENCY-REVERSING AGENTS

Chidamide

NCT02902185
(closed to enrollment)

Tang-Du Hospital

Phase II/III

December 2018

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
(closed to enrollment)

AIDS Clinical Trials Group/NIAID/Gilead

Phase I/II

May 2018

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 2017

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

NCT02191098

University of Minnesota - Clinical and Translational Science Institute

Phase I

December 2017

Kansui (traditional Chinese medicine containing ingenols)

NCT02531295
(suspended)

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

Sirolimus

NCT02440789

ACTG

Phase I/II

January 2018

metformin

NCT02659306

McGill University Health Center

Phase I

April 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

IMPAACT/NIAID/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

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

NCT02888756

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

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
(not yet open for enrollment)

Janssen Vaccines & Prevention B.V.

Phase I

February 2020

Ad26.Mos.HIV + MVA-Mosaic

NCT02919306

Janssen Vaccines & Prevention B.V.

Phase I

May 2019

DNA.HTI + MVA.HTI

NCT03204617
(closed to enrollment)

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

Recombinant adenovirus type 5 vaccine

NCT02762045

Centers for Disease Control and Prevention, China

Phase I

December 2017

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 multidrug 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

September 2017

DRONE: Impact of starting a dolutegravir-based regimen on HIV-1 proviral DNA reservoir of treatment naïve and experienced patients

NCT02370979
(closed to enrollment)

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 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

January 2018

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

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
(not yet open for enrollment)

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

February 2018

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 2017

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 (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
(closed to enrollment)

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

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

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

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
(not yet open for enrollment)

IrsiCaixa

N/A

December 2017

Post analytic treatment interruption study

NCT02761200

South East Asia Research Collaboration with Hawaii

N/A

June 2020

Predictors of time to viremia with an analytic treatment interruption

NCT03033017

University of Minnesota - Clinical and Translational Science Institute

N/A

July 2018

Quantitative measurement and correlates of the latent HIV reservoir in virally suppressed Ugandans

NCT02154035

NIAID

N/A

December 2019

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

NCT03117985

Centre Hospitalier Régional d'Orléans

N/A

February 2018

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

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

VRC01 (broadly neutralizing monoclonal antibody)

NCT02664415

National Institute of Allergy and Infectious Diseases (NIAID)

Phase II

IAS 2017, Abstract TUAB0106LB (slides, video)

3BNC117

NCT02018510

Rockefeller University

Phase I

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

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. doi: 10.20411/pai.v2i3.207

ANTI-INFLAMMATORY

CC-11050 (phosphodiesterase-4 inhibitor)

NCT02652546

NIAID

Phase I

N/A

ANTIRETROVIRAL THERAPY

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

N/A

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

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

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

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

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): 88390

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

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

NCT02443935

University of Aarhus

Phase Ib/IIa

Clin Infect Dis. 2017 Mar 9

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

J Clin Invest. 2017 Aug 1;127(8):3126-3135. doi: 10.1172/JCI92684

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

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

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

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

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):3519

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

N/A

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

HIV R4P 2014, Abstract OA05.03 (webcast)

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

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):2936

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):155361

AIDS. 2010 Oct 23;24(16):245160

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):32534

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):35564

Intense acute infection study

NCT01154673

University of Toronto

Phase II/III

N/A

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

alpha interferon intensification

NCT01295515

NIAID

Phase I/II

N/A

indinavir + zidovudine + lamivudine + nevirapine

NCT00001644

NIAID

Phase I

N/A