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A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online registry. Click the trial registry identifier numbers for a link to the full entry containing detailed information on the trial design, enrollment criteria, principal investigators and location(s). It’s important to appreciate that at the current time, none of these studies is expected to produce a cure for HIV infection—they represent research working toward that goal.

Entries shaded in light grey include analytical treatment interruptions (ATIs); in some cases the ATIs are only initiated if certain outcomes are achieved. Table 3 contains completed studies, with links to published or presented results where available. Changes from the previous update are highlighted in yellow. Starting in 2023, explanatory background on each monthly update will be posted to the TAG BSVC Project blog. Additional information on current approaches in HIV cure research can be found in TAG’s annual pipeline report. Please send updates, corrections, or suggestions to Richard Jefferys at richard.jefferys@treatmentactiongroup.org.

For more detailed background, see: A Brief Guide to TAG’s Listing of Research Toward an HIV Cure Clinical Trials and Observational Studies.

10/20/22: Based on this listing, Treatment Action Group has created a resource on the demographics of participation in HIV cure-related clinical research. The resource includes a detailed Excel file and summary PDF table of reported demographics in cure-related studies for which results have been presented or published from the beginning of 2018 to date.

Treatment Action Group gratefully acknowledges the support of the Foundation for AIDS & Immune Research (FAIR) for our HIV cure-related information and advocacy resources.

March 15, 2024

Table 1. Current Clinical Trials

Trial

Trial Registry Identifier(s)

Sponsor(s)

Phase

Estimated End Date/Interim
Results

ADOPTIVE IMMUNOTHERAPY

AutoRESIST: HIV antigen-specific T-cells targeting conserved epitopes for treatment of HIV-associated
lymphoma

NCT04975698

Catherine Bollard, Children’s
Research Institute

Phase II

June 2026

AlloRESIST: Evaluate the safety, immunologic, and virologic responses of donor derived
HIV-specific T-cells in HIV+ individuals following allogeneic bone marrow
transplantation

NCT04248192

Catherine Bollard, Children’s
Research Institute

Phase I

April 2025

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

NCT03485963
(closed
to enrollment)

Children’s Research Institute

Phase I

December 2024

ANALYTICAL TREATMENT INTERRUPTION

Assessment of HIV remission in early treated individuals with the MHC B35/53Bw4TTC2 genotype

NCT05482854

ANRS

N/A

July 2025

SCOPE-ATI

NCT04359186

UCSF

N/A

June 2024
CROI 2024, Abstracts 446,
482

Strategies for an HIV
Cure 2023, Abstract PP64

Imaging and biopsy of individuals undergoing ATI

NCT05419024

National Cancer Institute (NCI)

Phase II

August 2026
CROI 2024, Abstract
502

Strategies for an HIV
Cure 2023, Abstract PP41

Front Med. 2022 Aug
22;9:979756.

ANTI-α4β7 INTEGRIN ANTIBODIES

vedolizumab (anti-αβ integrin antibody)

NCT03147859

Ottawa Hospital Research
Institute

Phase II

December 2023
BMJ Open. 2020; 10(10):e041359.
CROI 2019,
Abstract 393, Webcast

ANTI-INFLAMMATORY

Fecal Microbiota Transplantation (FMT)

NCT06022406
(not yet open for enrollment)

Jean-Pierre Routy, McGill University Health
Centre

Phase II

September 2025

ANTIRETROVIRAL THERAPY

IDOLTIB: Impact of dolutegravir + lamivudine simplification on HIV-1 reservoirs

NCT04034862
(closed to
enrollment)

University of Liege

Phase III

June 2023

BCL-2 ANTAGONISTS

venetoclax

NCT05668026
(not yet open for enrollment)

University of Aarhus

Phase I/IIb

March 2026

BISPECIFIC T-CELL ENGAGERS

GS-8588

No clinicaltrials.gov entry,
listed
on UPenn website

Gilead Sciences

Phase I

N/A

BROADLY NEUTRALIZING ANTIBODIES

VRC01 (analytical treatment interruption in HVTN 703/HPTN 081 AMP trial participants)

NCT04860323

HIV Vaccine Trials Network

N/A

November 2029

VRC01 (analytical treatment interruption in AMP trial participants)

NCT04801758
(closed to enrollment)

HIV Vaccine Trials Network

N/A

January 2030

10-1074-LS + 3BNC117-LS in primary HIV infection

NCT04319367

Imperial College London

Phase II

March 2025
IAS HIV Cure &
Immunotherapy Forum 2023

HIV Persistence Workshop 2022,
Abstracts OP 7.2, PP
8.11
(slides)
Trials. 2022 Apr
5;23(1):263

3BNC117-LS + 10-1074-LS

NCT05300035
(not yet open for enrollment)

French National Agency for
Research on AIDS and Viral Hepatitis (ANRS)

Phase II

December 2028

VRC07-523LS + PGT121.414.LS

NCT05719441
(not yet open for enrollment)

NIAID

Phase II

September 2028

3BNC117-LS-J + 10-1074-LS-J

NCT06031272
(not yet open for enrollment)

ACTG

Phase I

June 2026

3BNC117-LS + 10-1074-LS

NCT05612178

NIAID

Phase I

December 2025

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

NCT03374202
(closed
to enrollment)

NIAID

 

Phase I

August 2026
Nat Med.
28(5):1022-1030.

CROI 2022, Abstract 498
CROI 2021,
Abstract 160, Webcast
CROI 2020,
Abstract 41LB, Webcast

CAP256V2LS + VRC07-523LS

PACTR202309578224660
(not yet open for enrollment)

Centre for the AIDS Programme of
Research in South Africa (CAPRISA)

Phase I

October 2025

CD4 ATTACHMENT INHIBITORS

UB-421 (antibody inhibitor of HIV binding to
CD4 receptors)

NCT04404049
(not yet open for enrollment)

UBP Greater China (Shanghai) Co., Ltd

Phase II

June 2025

COMBINATIONS

VRC07-523LS, CAP256V2LS, vesatolimod

NCT05281510
(closed to enrollment)

Gilead Sciences

Phase IIa

March 2025

ASC22 (anti-PD-L1 antibody) + chidamide (HDAC inhibitor)

NCT05129189

Shanghai Public Health Clinical Center

Phase II

July 2023
IAS 2023,
Abstract LBEPB18

budigalimab (anti-PD-1 antibody) +/- ABBV-382 (anti-αβ integrin antibody)

NCT06032546

AbbVie

Phase II

November 2025

UB-421 + chidamide (antibody inhibitor of HIV binding to CD4 receptors + HDAC
inhibitor)

NCT04985890
(not yet open for enrollment)

UBP Greater China (Shanghai) Co.,
Ltd

Phase II

December 2027

Ad26.Mos4.HIV, MVA-BN-HIV, PGT121, PGDM1400, VRC07-523LS (therapeutic vaccines, broadly neutralizing antibodies)

NCT04983030

Boris Juelg, MD PhD

Phase I/IIa

April 2026

IMPAACT P1115 v2.0: Very early intensive treatment of HIV-infected infants to achieve HIV remission (ART +/VRC01)

NCT02140255

IMPAACT

Phase I/II

December 2031
CROI 2024, Abstracts 184,
954

Lancet HIV.
S2352-3018(23)00236-9.

Strategies for an HIV
Cure 2023, Abstract PP05

CROI 2022,
Abstract 31

Therapeutic conserved element DNA vaccine (IL-12 adjuvanted p24CE), MVA vaccine boost (MVA/HIV62B), TLR9 agonist (lefitolimod), broadly neutralizing antibodies (VRC07-523LS + 10-1074)

NCT04357821
(closed to enrollment)

UCSF

Phase I/II

December 2024
CROI 2024, Abstracts 446,
618

HIV Res Clin Pract.
25(1):2312318

Strategies for an HIV
Cure 2023, Abstract PP66

CROI 2023, Abstract 435

HVRRICANE: HIVIS DNA + MVA-CMDR vaccines +/- TLR4 agonist

NCT04301154

PENTA Foundation

Phase I

October 2023
CROI 2024, Abstract
408

N-803 (recombinant human super agonist interleukin-15 complex) +/- VRC07-523LS
+ 10-1074

NCT04340596

NIAID

Phase I

April 2026

N-803, 3BNC117-LS, 10-1074-LS

NCT05245292

Rockefeller University

Phase I

December 2025

VRC07-523LS, PGDM1400LS, N-803, Ad26.Mos4.HIV, MVA-HIV, A244d11gp120/ALFQ

NCT05769569
(not yet open for enrollment)

Henry M. Jackson Foundation for
the Advancement of Military Medicine

Phase I

July 2025

CYTOKINES

N-803 in acute HIV infection

NCT04505501

Thai Red Cross AIDS Research Centre

Phase II

June 2025

DUAL-AFFINITY RE-TARGETING (DART) MOLECULES

MGD020 +/- MGD014

NCT05261191

MacroGenics

Phase I

March 2024

GENE THERAPIES

EBT-101 (CRISPR/Cas9 targeting HIV provirus)

NCT05144386

Excision BioTherapeutics

Phase I/IIa

March 2025
ESGCT Congress 2023,
Abstract OR31

LVgp120duoCAR-T cells

NCT04648046

Steven Deeks, UCSF

Phase I/IIa

December 2027

Cal-1: Dual anti-HIV gene transfer construct

NCT02390297
(closed to enrollment)

Calimmune

Phase I/II

October 2031
CROI
2020,
Abstract 338

SB-728-T (autologous T cells gene-modified
to disrupt CCR5 receptor expression)

NCT03666871
(closed
to enrollment)

Case Western Reserve University

Phase I/II

February 2024

An ATI study to evaluate the impact of AGT103-T to suppress HIV replication in the absence of ART

NCT05540964
(enrolling by invitation)

American Gene Technologies
International Inc.

Phase I

July 2025
medRxiv 2023
10.24.23297421

CD4 CAR + SB-728mR modified T cells

NCT03617198
(closed to enrollment)

University of Pennsylvania

Phase I

December 2027
CROI 2022 (James L.
Riley)

Chimeric Antigen Receptor (CAR)-T cell therapy

NCT03240328

Guangzhou 8th People’s Hospital

Phase I

December 2030
JCI. 2021;150211

CMV-specific HIV-CAR T Cells

NCT06252402
(not yet
open for enrollment)

City of Hope Medical Center

Phase I

March 2028

EBT-101 (long-term follow-up study)

NCT05143307
(enrolling by invitation)

Excision BioTherapeutics

Phase I

April 2037

Long-term follow-up of study participants treated with AGT103-T

NCT05529342
(enrolling by invitation)

American Gene Technologies International Inc.

Phase I

September 2038

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

NCT02500849
(closed to enrollment)

City of Hope Medical Center

Phase I

August 2024

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

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

NCT02797470
(closed
to enrollment)

AIDS Malignancy Consortium

Phase I/II

June 2025

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

December 2024

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

December 2024

IMAGING STUDIES

Imaging immune activation in HIV by PET-MR

NCT03684655

University of California, San Francisco

Phase I

November 2024
CROI 2024, Abstract
105

Radiolabeled VRC01

NCT03729752

University of California, San Francisco

Phase I

January 2025
Nat Commun.
2022;13(1):1219.

CROI 2020,
Abstract 72

IMMUNE CHECKPOINT INHIBITORS

ASC22 (anti-PD-L1 antibody)

NCT05330143

Ascletis Pharmaceuticals Co., Ltd.

Phase II

December 2023

NIVO-LD: Low dose nivolumab in adults living with HIV on antiretroviral therapy

NCT05187429

University of Melbourne

Phase I/II

January 2026

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

July 2024
Cancer. 2023 Nov 14.
Clin Infect Dis. 2021
ciaa1530

HIV Persistence Workshop 2019,
Abstract OP 5.5
J Clin Oncol 36, no.
15_suppl

pembrolizumab (anti-PD-1 antibody)
in treating patients with HIV and relapsed, refractory, or disseminated malignant neoplasms

NCT02595866
(closed
to enrollment)

National Cancer Institute (NCI)

Phase I

October
2024
CROI 2023,
Abstract
181

Sci
Transl Med. 14(629):eabl3836

JAMA
Oncol. Sep 1;5(9):1332-1339

CROI 2019,
Abstract
27

CROI 2018,
Abstract
656LB

IMMUNOMODULATORS

lenalidomide, adenosylmethionine

NCT05598580

First Affiliated Hospital of
Zhejiang University

Phase IV

November 2024

JANUS KINASE INHIBITORS

baricitinib

NCT05452564
(suspended)

Emory University

Phase II

January 2028

LATENCY-REVERSING AGENTS

lauric acid

NCT05687565

Hospital Universitari Vall d’Hebron Research
Institute

N/A

December 2025

panobinostat, lenalidomide + pyrimethamine

NCT06240520
(not yet open for enrollment)

Erasmus Medical Center

Phase I/II

October 2025

topiramate

NCT06282783
(not yet open for enrollment)

Erasmus Medical Center

Phase I/II

August 2025

arsenic trioxide

NCT03980665

Guangzhou 8th People’s Hospital

Phase I

December 2025

decitabine, romidepsin

NCT05230368

ANRS

Phase I

April 2026

STEM CELL TRANSPLANTATION

Cord blood transplant with OTS for the
treatment of HIV+ hematologic cancers

NCT04083170

Fred Hutchinson Cancer Research Center

Phase II

December 2025

T-CELL RECEPTOR-BASED BISPECIFICS

IMC-M113V in HLA-A*02:01 positive people

2021-002008-11

Immunocore

Phase I/II

N/A

THERAPEUTIC VACCINES

BELIEVE: BCG vaccination effect on latent reservoir size in treated HIV-1 infection

NCT05004038
(closed
to enrollment)

University of Zurich

Phase IIa

January 2024

GS-1966/GS-1144 HIV vaccine regimens

No clinicaltrials.gov entry, #7 on Midway Research
Center list

Gilead Sciences

Phase Ib

N/A

426c.Mod.Core-C4b, 3M-052-AF + Alum (*primarily
focused on preventive HIV vaccine development but may also assist cure research)

NCT06006546

NIAID, HIV Vaccine Trials Network

 

Phase I

December 2025

ChAdOx1.HIVconsv62MVA.tHIVconsv4
(C62-M4)
, ChAdOx1.tHIVconsv1+C62-MVA.tHIVconsv3+M4 (C1C62-M3m4)

NCT05604209

University of North Carolina, Chapel Hill

Phase I

August 2024

DC-HIV04: a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides

NCT03758625
(closed
to enrollment)

Sharon Riddler, University of Pittsburgh

Phase I

March 2025

ICVAX: PD-1-enhanced HIV DNA vaccine

NCT06253533
(closed to enrollment)

Shenzhen Immuno Cure Biomedical Company
Limited

Phase I

January 2025
IAS HIV Cure &
Immunotherapy Forum 2023

NETI: Trimer 4571 therapeutic vaccination

NCT04985760

NIAID

Phase I

November 2025

Therapeutic vaccine based on aDC1 dendritic cells

NCT05786937
(not yet open for enrollment)

University of Sao Paulo General
Hospital

Phase I

December 2023

TREATMENT INTENSIFICATION/EARLY TREATMENT

DGVTAF: Immediate initiation of antiretroviral
therapy during “hyperacute” HIV infection

NCT02656511
(closed
to enrollment)

UCSF

Phase IV

April 2025
CROI 2024, Abstracts 468,
508
IAS 2023, Abstract
2167

AAHIV: Antiretroviral therapy for acute HIV infection

NCT00796263

South East Asia Research Collaboration with
Hawaii

Phase III

June 2033
See supplemental
references page

EIT: Early infant HIV treatment in Botswana

NCT02369406
(closed
to enrollment)

Harvard School of Public Health

Phase II/III

June 2029
JAIDS 2022 Dec 12
CROI 2022,
Abstract 712
Clin Infect Dis. 2021
ciab143

Clin Infect Dis. 2020
Jan 12.

Sci Transl Med. 2019
Nov 27;11(520). pii: eaax7350

CROI
2019,
Poster abstract 826
CROI
2018,
Abstract 136

EARLIER: Early ART to limit infection and establishment of reservoir

NCT02859558
(closed
to enrollment)

AIDS Clinical Trials Group

Phase II

April 2025
Clin Infect Dis. 2021
Aug 2;73(3):e643-e651

TYROSINE KINASE INHIBITORS

dasatinib

NCT05527418

Eva Bonfill, Institut d’Investigacions
Biomèdiques August Pi i Sunyer

Phase II

June 2026

dasatinib

NCT05780073

Fundació Institut Germans Trias i Pujol

Phase II

March 2025

 

Table 2. Current Observational Studies

Trial

Trial Registry Identifier(s)

Manufacturer/
Sponsor(s)

Phase

Estimated End Date/Interim
Results

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

NCT03449706

University Hospital, Ghent

N/A

January 2028

Analytic treatment interruption (ATI) to assess HIV cure

NCT02437526
(enrolling by invitation)

Mayo Clinic

N/A

May 2025
PLoS Med. 2017 Nov
28;14(11):e1002461.

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

NCT03354936

Inserm-ANRS

N/A

June 2022
Cells. 2022 Mar
17;11(6):1015.

AIDS
2020,
Abstract OAB0203

APRIL: Analysis of the persistence, reservoir and
HIV latency

NCT05752318

University Hospital, Strasbourg, France

N/A

February 2027
Pathog
Immun. 8(2):92-114.

ARCH: Analysis of the reservoir in individuals
controlling HIV infection

NCT06016114
(not yet open for enrollment)

Sponsor University Hospital, Ghent

N/A

October 2028

ATGALIG-HIV: Study of autophagy and the effects
of GALIG gene products in HIV-1+ patients on antiretroviral therapy since primary infection, chronic phase, or never treated

NCT04160455

Centre Hospitalier Régional d’Orléans

N/A

November 2039

BICTEVOIR: A study to determine the cartography
of virologic reservoir related to antiretroviral concentrations in HIV-1+ patients on first line treatment containing bictegravir, emtricitabine and tenofovir alafenamide

NCT05222945
(not yet open for enrollment)

 

ANRS

 

 

N/A

March 2024

Characterization of acute and recent HIV-1 infections in Zurich: a long-term observational study

NCT00537966

University of Zurich

N/A

January 2025
Microorganisms. 12(2):302
CROI 2023,
Abstract 387

CHRONO: A prospective cohort for ex vivo cure
studies with chronic HIV+ patients in the Netherlands

NCT04888754
(closed
to enrollment)

Erasmus Medical Center

N/A

January 2034

CODEX (the Extreme cohort, ANRS CO21)

NCT01520844

Inserm-ANRS

N/A

September 2023
See supplemental
references page

Comparing immune activation and HIV reservoir
size between PWHIV on tenofovir-containing versus NRTI-free ART

NCT05584397
(enrolling
by invitation)

University of Washington

N/A

February 2025

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

NCT03215004
(closed
to enrollment)

American Gene Technologies International Inc.

N/A

February 2021

Early antiretroviral treatment in HIV+
children

NCT05784584
(closed to enrollment)

PENTA Foundation

N/A

February 2024

Establish and characterize an acute HIV
infection cohort in a high-risk population

NCT00796146

Southeast Asia Research Collaboration with
Hawaii

N/A

July 2033
See supplemental
references page

Evaluation of the role of HIV-1 Tat protein
and anti-Tat immune response in HIV reservoir (ISS OBS T-005)

NCT04263207
(suspended)

Barbara Ensoli, MD, PhD, Istituto Superiore
di Sanità

N/A

January 2024

Extended follow-up of the ISS T-003 trial
volunteers (ISS T-003 EF-UP2020)

NCT05680948

Istituto Superiore di Sanità

N/A

June 2024

EX VIVO: Ex vivo characterization and
targeting of the latent HIV infected reservoir to cure HIV

NCT05215704

Erasmus Medical Center

N/A

December 2030

FRESH (Females rising through education, support,
and health)

Ragon Institute
webpage

(no clinicaltrials.gov entry)

Ragon Institute of MGH, MIT and Harvard

N/A

 

N/A
See supplemental
references page

HI-ART: Optimising cohorts for HIV cure
interventions

NCT05852301

Bayside Health

N/A

 

December 2025

HIV-Mercuri: HIV study on measuring the reservoir
on cellular level to cure infection

NCT04305665

University Hospital, Ghent

N/A

December 2025

HUSH restriction in HIV+ patients

NCT04172480

Inserm-ANRS

N/A

September 2023

iCHIP: Effect of immune checkpoint inhibitors on
HIV persistence

hivcure.com.au (no registry entry)

University of Melbourne

N/A

N/A
J Immunol Methods.
2021 Dec 1;113198

AIDS. 2021 Apr 15.
CROI 2020,
Abstract 334

IciStem:
Collaborative project to guide and investigate the potential for HIV cure in
HIV+ patients requiring allogeneic stem cell transplantation for
hematological disorders

IciStem website (no clinicaltrials.gov
entry)

amfAR

N/A

N/A
IAS 2023,
Abstract OALBA0504
Viruses. 2022 Sep 17;14(9):2069.

CROI 2020, Abstract 339, Abstract 348LB
Lancet HIV 2020 Mar
9.

HIV Persistence Workshop 2019,
Abstract OP 4.5
Nature. 2019
Apr;568(7751):244-248.

CROI 2019,
Poster abstract 394
Ann Intern Med.
2018;169(10):674-683.

Identification and quantification of HIV CNS
latency biomarkers

NCT02989285

St Vincent’s Hospital, Sydney

 

N/A

December 2020
PNAS 119(48):
e2210584119.

Immuno-virological evaluation of persons
living with HIV (PLWH)

NCT05973825
(not yet open for enrollment)

University Hospital, Ghent

N/A

July 2029

Investigation of the impact of inducible,
replication-competent latent HIV-1 as an impediment to HIV/AIDS cure in the
context of sustained viral suppression

NCT04938518

Kenya Medical Research Institute

N/A

April 2022

LAMIVIH: Evolution of HIV reservoir,
inflammation, and microbiota footprint of PLWH switching to long-acting
injectable treatment

NCT05303337

Hôpital Européen Marseille

N/A

March 2024

Long-term clinical, immunologic, and
virologic profiles of children who received early treatment for HIV

NCT05154513

IMPAACT

N/A

November 2027

NOVA: Netherlands cohort study on acute HIV
infection

NCT05728996

Prof. Jan Prins

N/A

August 2028

PediacamNEG:
Negative serology in children with HIV treated early with ART

NCT06302933
(not yet open for enrollment)

Inserm-ANRS

N/A

August 2025

Post analytic treatment interruption study

NCT02761200

South East Asia Research Collaboration with
Hawaii

N/A

March 2031

PRIMO (ANRS CO6): Primary infection cohort

NCT03148964

Inserm-ANRS

N/A

September 2025
See supplemental
references page

Quantification of antisense HIV RNA

NCT05381844

Institut National de la Santé Et de la
Recherche Médicale, France

N/A

December 2024

RESERVIH32: Bioclinical evaluation of two
biomarkers of aviremic HIV-1 in CD4 T cells of adults undergoing treatment

NCT03940521

Centre Hospitalier Universitaire de Nīmes

N/A

September 2025

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

NCT03622177

Inserm-ANRS

N/A

September 2023
J Immunol. 2022 May
2;ji2100725.

Saturne-HIV: Sequential analysis before and after
treatment initiation to unravel the role of naturally occurring extracellular
vesicles in HIV infection

NCT04653610

University Hospital, Ghent

N/A

January 2027

The Gemini Study: Safety and survival of
genetically modified white blood cells in HIV+ twins

NCT04799483
(closed to enrollment)

NIAID

N/A

January 2030

The Last Gift Study (for people with HIV and
less than 6 months life expectancy due to terminal illness)

UCSD study website

University of California, San Diego (UCSD)

N/A

N/A
Strategies for an HIV
Cure 2023, Abstracts PP22 & PP73

J Virus Erad. 2023
Jun 5;9(2):100328.

Curr HIV/AIDS Rep.
2022 Oct 19;1-14.

J Med Ethics. 2022
Jun 22

PLoS One. 2021 May
7;16(5):e0250882.

J Clin Invest. 2020
Jan 7

HIV Persistence Workshop 2019, Abstract PP 5.7.5 (see
abstract book)

The role of the gastrointestinal-associated
lymphoid tissue in the cure of HIV infection

NCT05652088

Icahn School of Medicine at Mount Sinai

N/A

May 2024

The use of leukapheresis to support HIV
pathogenesis studies

NCT01161199

University of California, San Francisco

N/A

July 2033

Thinking and memory problems in people with
HIV

NCT01875588

National Institute of Neurological Disorders
and Stroke (NINDS)

N/A

February 2037

TRESAX: T follicular helper reservoir in axillary
lymph nodes study

hivcure.com.au (no registry entry)

Kirby Institute

N/A

N/A

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

HIV-specific memory CD8 T cells
adoptive immunotherapy

ChiCTR-ICR-15005775

Beijing You’an Hospital, Capital
Medical University

Phase I

Front Immunol. 2019
Mar 18;10:437

HXTC: HIV 1
antigen expanded specific T cell therapy

NCT02208167

University of North Carolina,
Chapel Hill

Phase I

Mol Ther. 2018 Oct
3;26(10):2496-2506.

ANALYTICAL TREATMENT INTERRUPTION

TESOVIR:
Tracking and exploring the source of viral rebound

NCT03117985

Centre Hospitalier Régional
d’Orléans

N/A

Terminated (no interesting
results)

ANTIBODIES

CHERUB 001: IVIG in
primary HIV infection

No clinicaltrials.gov entry

CHERUB

N/A

HIV Med. 2017 Jul 18.

GSK3810109A (broadly neutralizing
antibody formerly named N6-LS)

NCT04871113

ViiV Healthcare

Phase IIa

EACS 2023, Abstracts PS8.O5 & eP.A.099
CROI 2023,
Abstract 520
HIV Glasgow 2022,
Abstract O34

3BNC117 (broadly neutralizing monoclonal
antibody)

NCT02446847

Rockefeller University

Phase II

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

3BNC117

NCT02588586

Rockefeller University

Phase II

N/A

UB-421 (antibody inhibitor of HIV binding to
CD4 receptors)

NCT03743376

United BioPharma

Phase II

N/A

UB-421

NCT02369146

United BioPharma

Phase II

N Engl J Med.
2019;380(16):1535-45

vedolizumab (anti-αβ
integrin antibody)

NCT03577782

Hospitales Universitarios Virgen del Rocío

Phase II

XI Congreso Nacional GeSIDA, Abstract PO-48 (video)

VRC01 (broadly neutralizing monoclonal antibody)

NCT02664415

National Institute of Allergy and Infectious
Diseases (NIAID)

Phase II

J Clin Invest.
130(6):3299-3304.

Lancet HIV. 2019
May;6(5):e297-e306.

IAS 2017, Abstract
TUAB0106LB (slides, video)

PGT121 +
VRC07-523LS
+/- PGDM1400
(broadly neutralizing antibodies)

NCT03721510

International AIDS Vaccine
Initiative

Phase I/IIa

CROI 2024,
Abstracts 121,
483

VRC01 (broadly neutralizing antibody) in
infants

NCT03208231

NIAID

Phase I/II

AIDS 2022, Abstract OALBB0102

VRC01LS + 10-1074 (broadly
neutralizing antibodies)
in early-treated children

NCT03707977

NIAID

Phase I/II

Sci Transl Med. 2023
15(703):eadh0004.

CROI 2023, Abstracts
141, 828
JAIDS. 2022 Oct
1;91(2):182-188.

CROI 2022,
Abstract 32
CROI 2021,
Abstract 609, Webcast

ABBV-382 (anti-αβ integrin antibody)

NCT04554966

AbbVie

Phase Ib

N/A

10-1074 (broadly neutralizing monoclonal
antibody)

NCT02511990

Rockefeller University

Phase I

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

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

NCT03554408

Rockefeller University

Phase I

N/A

3BNC117

NCT02018510

Rockefeller University

Phase I

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

3BNC117 + 10-1074

NCT03571204

NIAID

Phase I

Nature. 2022 Jun;
606(7913):375-381.

3BNC117 + 10-1074

NCT02825797

Rockefeller University

Phase I

Nat Med. 2020
Feb;26(2):222-227

Nature. 2018
Sep;561:479-484.

Nat Med. 2018 Sep 26.

3BNC117 + 10-1074

NCT03526848

Rockefeller University

Phase I

Nature. 2022 Apr 13
CROI 2022,
Abstract 361

3BNC117-LS + 10-1074-LS in viremic HIV+
individuals

NCT04250636

Rockefeller University

Phase I

CROI 2022, Abstract 140

3BNC117-LS

NCT03254277

Rockefeller University

Phase I

N/A

elipovimab (formerly GS-9722; PGT121-derived
broadly
neutralizing antibody)

GS-US-420-3902 Adisinsight entry

Gilead Sciences

Phase I

CROI 2022, Abstract 349
CROI 2020,
Abstract 39, Webcast

PGDM1400 +/– PGT121 +/– VRC07-523LS (broadly
neutralizing antibodies)

NCT03205917

International AIDS Vaccine Initiative

Phase I

Nat Med. 2022 May 12.
CROI 2022,
Abstract 139

PGT121

NCT02960581

International AIDS Vaccine Initiative

Phase I

Nat Med. 2021 Oct 7.
CROI 2019,
Abstract 145, Webcast

SAR441236 (tri-specific broadly neutralizing
antibody)

NCT03705169

NIAID

Phase I

CROI 2024, Abstract
118

Results posted in
clinicaltrials.gov

vedolizumab

NCT02788175

NIAID

Phase I

AIDS 2018, WESS0102

VRC01 + 10-1074

NCT03831945

NIAID

Phase I

N/A

VRC01 in acute HIV infection

NCT02591420

NIAID

Phase I

CROI 2023, Abstract 430

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

CROI 2023, Abstract 390
HIV Persistence Workshop 2022,
Abstract PP 4.10 (slides)
N Engl J Med.
375(21):2037-2050

CROI 2016, Abstract 32LB,
Webcast

VRC01

NCT01950325

NIAID

Phase I

Sci Transl Med.
7(319):319ra206

VRC01LS, VRC07-523LS (long-acting broadly neutralizing
antibodies)

NCT02840474

NIAID

Phase I

IAS 2019, Abstract WEAA0305LB (video, at 45:36)

ANTI-CMV THERAPY

letermovir (Prevymis)

NCT04840199

NIAID

Phase II

CROI 2024, Abstract
354

ANTI-FIBROTIC

ACE inhibitors

NCT01535235

UCSF/amfAR

Phase IV

Pathog Immun.
2017;2(3):310-34.

losartan

NCT01852942

University of Minnesota

Phase II

CROI 2020, Abstract 277

telmisartan

NCT01928927

AIDS Clinical Trials Group

Phase II

CROI 2019, Abstract 395

J Infect Dis. 2018
May 5;217(11):1770-1781

telmisartan

NCT02170246

Yale University

Phase I

CROI 2019, Abstract 300

ANTI-INFLAMMATORY

canakinumab (IL-1β inhibitor)

NCT02272946

University of California, San Francisco

Phase II

J Am Coll Cardiol.
72(22):2809-2811.

CROI 2017,
Abstract 126, Webcast

CD24Fc (human CD24 extracellular domain and human
IgG1 Fc fusion protein)

NCT03960541

OncoImmune, Inc.

Phase II

“Terminated (Business Reasons)”

High dose vitamin D supplementation

NCT03426592

University of Melbourne

Phase II

J Virus Erad. 2023
Aug 29;9(3):100345.

CROI 2022,
Abstract 355

Camu Camu (Myrciaria dubia)

NCT04058392

McGill University Health Centre

Phase I

N/A

CC-11050 (phosphodiesterase-4 inhibitor)

NCT02652546

NIAID

Phase I

OFID. 6(6):ofz246.
AIDS 2018,
Poster abstract
LBPEB021

ANTI-PROLIFERATIVE

mycophenolate mofetil (MMF)

NCT03262441

Fred Hutchinson Cancer Research Ctr

Phase I

OFID 2022, ofac620
CROI 2020,
Abstract 340

ANTIRETROVIRAL THERAPY

dolutegravir in reservoirs

NCT02924389

Emory University

Phase IV

AIDS. 2018 Sep
24;32(15):2151-2159.

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

doravirine concentrations and antiviral
activity in cerebrospinal fluid

NCT04079452

Fundacio Lluita Contra la SIDA

Phase III

Clin Infect Dis. 2021
Sep 21;ciab835.

ABX464

NCT02735863

Abivax S.A.

Phase II

J. Virus Eradication
2019;5:10–22

ABX464

NCT02990325

Abivax S.A.

Phase I/II

 

J Infect Dis.
jiad251.

Clin Infect Dis. 2021
Aug 26:ciab733.

CROI 2020,
Abstract 335
HIV Persistence Workshop 2019, Abstract OP 8.3 (see
abstract book)

ANTIRETROVIRAL THERAPY IN HIV CONTROLLERS

emtricitabine + rilpivirine
+ tenofovir

NCT01777997

AIDS Clinical Trials Group/NIAID

Phase IV

J Infect Dis. 2020
June 4:jiaa294

Clin Infect Dis. 2019
May 25.

CROI 2019,
Poster abstract 508
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

ACTRN
12617000025336

Biotron Limited

Phase II

J Infect Dis. 2021
Jun 4;223(11):1914-1922.

CROI 2020,
Abstract 506
HIV DART 2018

BIT225

ACTRN
12612000696897

Biotron Limited

Phase I

J Antimicrob
Chemother. 2016 Mar;71(3):731-8

CANNABINOIDS

GALIG-CBD: Effects of cannabidiol on the
activation of autophagy and inflammation genes

NCT05306249

Centre Hospitalier Régional d’Orléans

Phase II

N/A

TN-TC11M2, TN-C200M2 oral capsules

NCT03550352

McGill University Health Center

Phase II

IAS 2023, Abstract EPB0270
Cells. 2023 Jul
8;12(14):1811.

Biomedicines. 2022 Dec 7;10(12):3168.

COMBINATIONS

maraviroc, dolutegravir,
dendritic cell vaccine, auranofin, nicotinamide

NCT02961829

Federal University of São Paulo

Not listed

CROI 2023, Abstract 383
CROI 2021,
Abstract 313
AIDS Res Ther. 2022
Jan 12;19(1):2.

AIDS 2020,
Abstract OAXLB0105
HIV Persistence Workshop 2019, Abstract OP 8.6 (see
abstract book)
Int J Antimicrob
Agents. pii: S0924-8579(19)30212-2.

CROI 2019,
Poster abstract 399
AIDS 2018, Abstract WEPDB0105 (
slides, video)

Perturbing of HIV reservoir with immune
stimulation:
Fluarix,
Pneumovax vaccines

NCT02707692

University of California, San Diego

Not listed

Results posted in
clinicaltrials.gov

ART +/-
cyclosporine A
, GM-CSF, pegylated interferon-alpha2b, IL-2

NCT00979706

Juan A. Arnaiz

Phase IV

AIDS 2022, Abstract OAA0205

MVA.HTI +
ChAdOx1.HTI
therapeutic vaccines + vesatolimod (TLR7
agonist)

NCT04364035

Aelix Therapeutics

Phase IIa

CROI 2023, Abstract 433
HIV Persistence Workshop 2022,
Abstract PP 7.4

ROADMAP: romidepsin
+ 3BNC117

NCT02850016

Rockefeller University

Phase IIa

Lancet Microbe. 2022
Mar;3(3):e203-e214

CROI 2020,
Abstract 38, Webcast

TITAN:
lefitolimod + 3BNC117 + 10-1074 (TLR9 agonist + broadly neutralizing
antibodies)

NCT03837756

University of Aarhus

Phase IIa

Nat Med. 2023 Sep 11
CROI 2023,
Abstract 136

Adoptive transfer of haploidentical
natural killer cells
and IL-2

NCT03346499

University of Minnesota – Clinical and
Translational Science Institute

Phase II

J Infect Dis. 2024
Jan 11:jiad578

Albuvirtide (fusion
inhibitor) +
3BNC117

NCT04819347

 

Frontier Biotechnologies Inc.

Phase II

N/A, unknown if study opened

eCLEAR:
romidepsin + 3BNC117

NCT03041012

Aarhus University Hospital

Phase II

HIV Persistence Workshop 2022, Abstract OP 1.9 (slides)
Nat Med. 2022 Oct 17

CROI 2022,
Abstract 62, Abstract 122

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

Lancet HIV. 2015
Mar;2(3):e82-91

CROI 2014, Poster abstract 422

MVA HIV-B +/- vedolizumab (viral vector vaccine
+/- anti-α
β integrin antibody)

NCT04120415

ANRS

Phase II

Stopped due to logistical issues

Research in Viral Eradication of HIV
Reservoirs (RIVER)
:
ART, ChAdV63.HIVconsv & MVA.HIVconsv vaccines, vorinostat

NCT02336074

Imperial College London

Phase II

CROI 2024, Abstract 504
Sci
Rep. 2023 Oct 11;13(1):17155.

J
Virus Erad. 2021 Sep 14; 7(3):100056.

Lancet.
2020 Mar 14;395(10227):888-898

AIDS 2018, Abstract TUAA0202LB (slides, video)

UB-421 +
chidamide

NCT05056974

United BioPharma

Phase II

N/A

vorinostat +/- tamoxifen
in postmenopausal women

NCT03382834

NIAID

Phase II

Clin Infect Dis. 2022
Feb 17:ciac136.

CROI 2020,
Abstract 333, Webcast
HIV Persistence Workshop 2019, Abstract OP 3.2

disulfiram + vorinostat

NCT03198559
(suspended
due to neurotoxicity)

The Peter Doherty Institute for Infection and
Immunity

Phase I/II

AIDS. 2021 Sep 29.
CROI 2019,
Abstract 401

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

NCT02972450

Inserm-ANRS

Phase I/II

Terminated due to bankruptcy of FITBiotech

panobinostat +
pegylated interferon-alpha2a

NCT02471430

Massachusetts General
Hospital

Phase I/II

Cell. 187(5):1238-1254.e14.
CROI 2022,
Abstract 357
CROI 2020,
Abstract 341

Vacc-4x
+ romidepsin

NCT02092116

Bionor Immuno AS/Celgene

Phase I/II

 

CROI 2023, Abstract 337
CROI 2019,
Abstract 397
Lancet HIV. 2016
Oct;3(10):e463-72

Vacc-4x
(peptide-based therapeutic vaccine) +
lenalidomide

NCT01704781

Bionor Immuno AS

Phase I/II

Results posted in
clinicaltrials.gov

vorinostat + hydroxychloroquine + maraviroc
(VHM)

NCT02475915
NCT02470351 (CNS substudy)

South East Asia Research Collaboration with
Hawaii

Phase I/II

J Virus Erad. 2020
(6) 100004

AIDS 2016,
Abstract TUAX0101LB

elipovimab (formerly
GS-9722) +/- vesatolimod

GS-US-420-3902 (#18 on list, no
clinicaltrials.gov entry)

Gilead Sciences

Phase Ib

N/A, elipovimab discontinued (see Adis Insight)

Adoptive transfer of haploidentical
NK cells
and N-803

NCT03899480

University of Minnesota – Clinical and
Translational Science Institute

Phase I

J Infect Dis. 2024
Jan 11:jiad578

AGS-004 + vorinostat

NCT02707900

NIAID

Phase I

Sci Rep. 2020 Mar
20;10(1):5134.

IAS 2019,
Poster abstract
MOPEB272

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

NCT01013415

University of Pennsylvania

Phase I

CROI 2020, Abstract 337, Webcast
Mol Ther. 2002
Jun;5(6):788-97

chemotherapy +
maraviroc
in people with non-Hodgkin lymphoma

NCT02486510

Fundacion para la Investigacion Biomedica del
Hospital Universitario Ramon y Cajal

Phase I

Terminated due to futility criteria

Chidamide + CAR-T
or TCR-T cell therapy

NCT03980691

Guangzhou 8th People’s Hospital

Phase I

N/A

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

NCT02767193

Judit Pich Martínez, Fundació
Clínic per la Recerca Biomèdica

Phase I

Front Immunol. 2021
Nov 11;12:767370.

CROI 2020,
Abstract 282
J Infect Dis. 2020;
221(10):1740-1742.

MVA-B (viral
vector vaccine)
+/- disulfiram

NCT01571466

Hospital Clinic of
Barcelona/HIVACAT

Phase I

PLoS One. 2015 Nov
6;10(11):e0141456.

JAC. pii: dkv046.

MVA.HIVconsv
+ romidepsin

NCT02616874

IrsiCaixa

Phase I

 

EBioMedicine. 2023
Jul 26;95:104732.

CROI 2023, Abstracts
385, 481
Microbiome. 2022 Apr
11;10(1):59.

EBioMedicine. 2022
Mar 21;78:103956.

AIDS. 2021 Nov 3
JAC. 2020 Dec
22;dkaa523.

Front Immunol. 2020
May 6;11:823.

CROI 2019,
Abstract 438
CROI 2017,
Abstract 119LB, Webcast

peginterferon
alfa-2b
+ 3BNC117 + 10-1074 (BEAT-2)

NCT03588715

Wistar Institute

Phase I

CROI 2024,
Abstracts 179,
511,
1091,
1106

HIV Res Clin Pract.
24(1):2267825.

CROI 2023, Abstracts
319, 326, 384, 431
HIV Persistence Workshop 2022,
Abstracts PP 7.2,
8.10

CROI 2022,
Abstract 352

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

NCT03212989

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

Phase I

J Infect Dis.
jiad423.

IAS 2023,
Abstract TUPEA02

VRC07-523LS + vorinostat

NCT03803605

University of North Carolina, Chapel Hill

Phase I

J Infect Dis.
jiab487.

IAS 2021,
Abstract OALA01LB03 (video)

CYTOKINES

interleukin-2 (IL-2)

NCT03308786

Case Western Reserve University

Phase II

HIV Persistence Workshop 2022, Abstract OP 8.2 (slides)

Effect of N-803 on B cell
follicles

NCT04808908

University of Minnesota

Phase I

N/A

N-803

NCT02191098

University of Minnesota – Clinical and
Translational Science Institute

Phase I

Nat Med. 2022 Jan 31.
CROI 2018,
Poster abstract 356

DUAL-AFFINITY RE-TARGETING (DART) MOLECULES

MGD014

NCT03570918

MacroGenics

Phase I

AIDS 2022, Abstract OAA0403
Results posted in
clinicaltrials.gov

GENE THERAPIES

OZ1

NCT00074997

Janssen-Cilag Pty Ltd

Phase II

Nat Med. 2009 Mar;
15(3): 285–292.

Cal-1: Dual anti-HIV gene transfer construct

NCT01734850

Calimmune

Phase I/II

Results posted in
clinicaltrials.gov

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 2023, Abstract 182
bioRxiv 2021.02.28

CROI 2016,
Poster abstract 358LB

CROI 2015, Poster abstract 434

CROI 2014, Abstract 141, Webcast

SB-728-T

NCT01252641

Sangamo BioSciences

Phase I/II

N/A

VRX496 (gene-modified autologous CD4 T cells)

NCT00295477

University of Pennsylvania

Phase I/II

Blood. 2013 Feb 28;
121(9): 1524–1533

AGT103-T (gene-modified HIV-specific CD4 T
cells)

NCT04561258

American Gene Technologies International Inc.

Phase I

Front Med 2022
9:1044713.

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

NCT03020524

University of Pennsylvania

 

Phase I

N/A

HGTV43

No clinicaltrials.gov entry

Enzo Biochem

Phase I

AIDS 2006, Abstract MOPDA06

Long-term follow-up of HIV+ participants
exposed to SB-728-T or SB-728mR-T

NCT04201782

Sangamo Therapeutics

Phase I

No significant safety issues in any participants
exposed 7.5 – 13.5 years ago

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

NCT01787994

Takara Bio/University of Pennsylvania

Phase I

Mol Ther 2020 Nov 10
CROI 2015,
Poster abstract 402

Redirected high affinity Gag-specific T cells

NCT00991224

University of Pennsylvania/Adaptimmune

Phase I

Study closed (safety): Mol Ther. 2015 Jul;
23(7): 1149–1159.

SB-728mR-T +
cyclophosphamide

NCT02388594

University of Pennsylvania

Phase I

J Clin Invest. 2021.
CROI 2019,
Abstract 25, Webcast

SB-728-T

NCT01044654

Sangamo BioSciences

Phase I

CROI 2023, Abstract 182
bioRxiv 2021.02.28
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

shRNA-modified CD34+ cells

NCT03517631

Shanghai Public Health Clinical Center

Phase I

N/A

TCTIWHI: Third-generation CAR-T-cell therapy

NCT04863066

Beijing 302 Hospital

Phase I

N/A

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

CRISPR CCR5 modified CD34+ cells

NCT03164135

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

Not listed

N Engl J Med. 2019
Sep 11

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

NCT00858793

Universitätsklinikum Hamburg-Eppendorf

Phase I/II

N/A

Stem cells gene-modified with Cal-1

NCT03593187

Assistance Publique – Hôpitaux de
Paris

Phase I/II

Mol Ther Methods Clin
Dev. 2019;13:303-309

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

NCT00569985

City of Hope Medical Center

Phase I

Sci Transl Med. 2010
Jun 16; 2(36): 36ra43.

GONADOTROPIN-RELEASING HORMONE (GnRH) AGONISTS

triptorelin acetate depot

NCT03536234

Immune System Regulation AB

Phase II

N/A

HORMONES

somatotropin (human growth
hormone)

NCT03091374

McGill University Health Center

Phase II

CROI 2021, Abstract 298, Webcast

IMAGING STUDIES

123I radiolabeled 3BNC117

NCT03468582

University of Lausanne Hospitals

Phase I

N/A

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

NCT03063788

Bayside Health

Phase I

EBioMedicine. 2021
Feb 25;65:103252.

AIDS 2020,
Abstract PEA0060

IMMUNE CHECKPOINT INHIBITORS

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

NCT03094286

Spanish Lung Cancer Group

Phase II

ESMO 2020, Abstract 1275P
JAMA Oncol. 2020 Jul
1;6(7):1063-1067

cemiplimab (anti-PD-1 antibody)

NCT03787095

NIAID

Phase I/II

OFID 11(3):ofad694.
J Acquir Immune Defic
Syndr. 87(5):e234-e236.

Pre-CROI Community HIV Cure Research Workshop 2020 (
slides, video)
ACTG announcement

budigalimab (anti-PD-1
antibody)

NCT04223804

AbbVie

Phase Ib

CROI 2024, Abstract
106

EACS 2023,
Abstract PS10.O3

BMS-936559 (anti-PD-L1 antibody)

NCT02028403

National Institute of Allergy and Infectious
Diseases (NIAID)

Phase I

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

CROI 2016, Abstract 25, Webcast

budigalimab (anti-PD-1 antibody)

NCT04799353

AbbVie

Phase I

EACS 2023, Abstract PS10.O3

ipilimumab (anti-CTLA-4 antibody)

NCT03407105

Medarex

Phase I

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

pembrolizumab (anti-PD-1 antibody) single
dose

NCT03239899

National Institute of Neurological Disorders
and Stroke (NINDS)

Phase I

HIV Persistence Workshop 2022, Abstract OP 1.10 (slides)

IRON CHELATORS

deferiprone

NCT02456558

ApoPharma

Phase I

N/A

JANUS KINASE INHIBITORS

ruxolitinib

NCT02475655

NIAID

Phase II

CROI 2024, Abstract
521

IAS 2023,
Abstract TUPEB15
J Clin Pharmacol.
2021 Jun 24.

Clin Infect Dis. 2021
ciab212

CROI 2019,
Abstract 37

LATENCY-REVERSING AGENTS

disulfiram

NCT01286259

University of California, San Francisco/
Johns Hopkins University/amfAR

Not specified

Clin Infect Dis. 2014
58 (6): 883–90

Chidamide

NCT02902185

Tang-Du Hospital

Phase II/III

N/A

vorinostat (HDAC inhibitor)

NCT01365065

Bayside Health/Merck

Phase II

PLoS Pathog.
2014;10(10): e1004473

valproic acid (HDAC inhibitor)

NCT00289952

McGill University

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

HIV Med. 2020
Dec;21(11):747-757.

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

CROI 2015, Abstract 109, Webcast

The Lancet HIV. 2014
Oct; 1(1): e13–e21

romidepsin (HDAC inhibitor)

NCT01933594

AIDS Clinical Trials Group/NIAID/Gilead

Phase I/II

 

The Journal of
Infectious Diseases, jiaa777

CROI 2019,
Abstract 26, Webcast
CROI 2018,
Abstract 72, Webcast

valproic acid + pyrimethamine

NCT03525730

Erasmus Medical Center

Phase I/II

Sci Adv. 2023 Mar
17;9(11):eade6675.

vorinostat

NCT01319383

University of North Carolina at Chapel
Hill/NIAID/Merck

Phase I/II

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

J Infect Dis. 2014
Sep 1;210(5):728-35

Nature. 2012 Jul
25;487(7408):482-5

bryostatin 1 (PKC agonist)

NCT02269605

Fundacion para la Investigacion Biomedica del
Hospital Universitario Ramon y Cajal

Phase I

AIDS. 2016 Jun
1;30(9):1385-92.

Euphorbia kansui

NCT04503928

Shanghai Public Health Clinical Center

Phase I

N/A, unknown if study opened

Kansui (traditional Chinese medicine with
ingenols)

NCT02531295

UCSF

Phase I

Study terminated

mTOR INHIBITORS

Impact of Everolimus on HIV
persistence post kidney or liver transplant

NCT02429869

UCSF

Phase IV

Am J Transplant. 2020
Aug 11

metformin

NCT04500678

University of Hawaii

Phase II/III

AIDS Res Hum
Retroviruses. 2021 Jan;37(1):24-33.

Sirolimus

NCT02440789

ACTG

Phase I/II

CROI 2019, Abstract 131, Webcast

metformin

NCT02659306

McGill University Health Center

Phase I

EBioMedicine 65
(2021) 103270

CROI 2020,
Poster abstract 229
CROI 2019,
Poster abstract 301

OBSERVATIONAL STUDIES

2000HIV: 2000 HIV human functional genomics
partnership program

NCT03994835

Radboud University

N/A

CROI 2024, Abstracts 319,
442,
515

Front Immunol. 2022
Dec 20;13:982746

2000HIVTrained: 2000 HIV trained
innate immunity in HIV elite controllers

NCT04968717

Radboud University

N/A

CROI 2024, Abstract
442

CROI 2023, Abstracts
313, 314

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

 

CROI 2023, Abstracts 392, 398
J Infect Dis. 2023
Feb 10:jiad039.

HIV Persistence Workshop 2022,
Abstract PP 7.8
AIDS. 2022 Jun 23.
Front Cell Infect
Microbiol. 12:757846.

J Infect Dis.
2022:jiac030

CROI 2021,
Abstract 241, Webcast
HIV Persistence Workshop 2019, Abstracts OP 4.6, 5.6 & PP 4.4 (see
abstract book)
JAIDS. 2019 Aug
15;81(5):594-599.

CROI 2018, Abstract 119, Webcast
Poster abstract 403LB

PLoS Pathog. 2017
Sep;13(9):e1006629.

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

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

NCT03354936

 

Inserm-ANRS

N/A

Cells. 2022 Mar 17;11(6):1015.
AIDS
2020,
Abstract OAB0203

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

NCT01038401

Inserm-ANRS

N/A

N/A

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

N/A

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

NCT03198325

Ospedale San Raffaele

N/A

PLoS One. 2022 Mar
15;17(3):e0265348.

Viruses. 2021 Jul
19;13(7):1403.

AIDS: May 14, 2021

J Antimicrob
Chemother. 2021 Mar 7:dkab060.

Antimicrob Chemother.
2020 Jun 15:dkaa231.

HIV Persistence Workshop 2019, Abstract PP 5.7.10 (see
abstract book)
J Antimicrob
Chemother. 2019 April 23. pii: dkz138

ATN 147

ATN Cares website

The Adolescent Medicine Trials Network for
HIV/AIDS Interventions (ATN)

N/A

CROI 2023, Abstract 457

Biomarkers to predict time to
plasma HIV RNA rebound (ACTG A5345)

NCT03001128

AIDS Clinical Trials Group

N/A

JCI Insight. 9(3):e173864
CROI 2023, Abstracts
337, 380
HIV Persistence Workshop 2022,
Abstracts OP 7.3, PP
7.9
(slides)
AIDS Res Hum
Retroviruses. 2022 Mar 24.

CROI 2022,
Abstract 379
Clin Infect Dis. 2021
Jun 12;ciab541.

CROI 2021,
Abstract 311, Webcast
AIDS 2020,
Abstract PDB0102

CHERUB 003 (prospective HIV chemotherapy cohort
study)

NCT01902693

Imperial College London/CHERUB

N/A

N/A

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

NCT02674867

Inserm-ANRS

N/A

Front Immunol. 2021
Apr 22;12:662894.

Clin Infect Dis.
ciaa1931

AIDS 2018,
Abstract WEAB0208LB (slides)

DOLUVOIR: Cartography of virologic reservoir
related to antiretroviral concentrations in HIV-1+ patients on first line
treatment containing dolutegravir

NCT04133012

Inserm-ANRS

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.

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

 

AIDS. 34(5):687-697
Clin Infect Dis. 2019
Mar 28. pii: ciz251

AIDS
2014,
Abstract TUAB0206LB (video)
Clin Infect Dis.
(2014) 59 (7): 1012-1019.

Expectation, motivation, and experience of
HIV+ patients regarding participation to an HIV cure-related clinical trial
(AMEP-EHVA T02)

NCT05280392

ANRS

N/A

Abstract, AIDS Impact 2023

EURECA: Exploratory study of cellular reservoirs in
blood

NCT02858414

Centre Hospitalier Universitaire de Besancon

N/A

Viruses. 2018 Apr
13;10(4).

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

NCT03618862

Hospices Civils de Lyon

N/A

N/A

Genotyping FcɣRs genes

NCT03130296

University Hospital, Strasbourg, France

N/A

Genes Immun. 2020
Aug;21(4):263-268

HCURE: Impact of HCV DAAs on antiviral
immunity & HIV reservoir in HIV-HCV coinfection

NCT03244371

Assistance Publique Hopitaux De Marseille

N/A

N/A

HEATHER: HIV reservoir targeting with early
antiretroviral therapy

UK CPMS17589

University of Oxford/Medical Research
Council/British HIV Association

N/A

Front Immunol. 2021;
12: 647688.

J Infect Dis. 2019
Nov 28. pii: jiz563

Mucosal Immunol. 2019
Sep;12(5):1212-1219.

HIV-PRADA: HIV persistence in lymph node and
peripheral blood

NCT03426189

University of Melbourne

N/A

Cell Rep Med. 2022
Sep 28:100766

CROI 2021,
Abstract 301, Webcast

HIV resistance and treatment strategies

NCT00581802

NIAID

N/A

N/A

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

NCT02641756

University Hospital, Ghent

 

N/A

Cell Rep. 2022 Apr
26;39(4):110739.

IAS 2021,
Abstract PEA036 (poster, video)
J Virus Erad. 2021
Jan 23;7(1):100029.

CROI 2020,
Abstract 324
Cell Host Microbe.
2019 Sep 11;26(3):347-358.e7.

AIDS 2018, Abstract
WEAA0201 (slides, video), poster
abstract
THPEB096

Host & viral factors associated with HIV
elite control

UK CPMS16146

University College London Hospitals NHS
Foundation Trust

N/A

N/A

HSCT-HIV: Allogeneic hematopoietic stem cell transplantation
in HIV+ patients

NCT02732457

Kirby Institute

N/A

Terminated by Protocol Steering Committee

ImmunoCo27: Co-adaptation between HIV and CD8
cellular immunity

NCT02886416

Inserm-ANRS

N/A

N/A

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

NCT03416790

IMPAACT

N/A

N/A

Impact of ART adherence on HIV persistence
and inflammation

NCT02797093

University of Colorado, Denver

N/A

N/A

Impact of a short-term ATI and
re-initiation of antiretroviral therapy on immunologic and virologic
parameters in HIV+ individuals

NCT03225118

NIAID

N/A

J Infect Dis. 2020
May 22:jiaa270.

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

Strategies for an HIV
Cure 2023, Abstract PP20

IAS 2023,
Abstract TUPEA07
J Int AIDS Soc. 2020
Feb;23(2):e25453.

CROI 2019,
Poster abstract 389, Webcast

Long-term effects of ART in acute HIV
infection

ChiCTR1800015006

Key Laboratory of AIDS Immunology of National
Health and Family Planning Commission, The First Affiliated Hospital, China
Medical University

N/A

N/A

LoViReT: Low viral reservoir treated patients

NCT02972931

IrsiCaixa

N/A

HIV Persistence Workshop 2022, Abstract PP 3.13
J Intern Med. 2022
Mar 28.

EBioMedicine. 2020
Jun 21;57:102830.

CROI 2020,
Abstract 374
HIV Persistence Workshop 2019, Abstract OP 3.5 (see
abstract book)
HIV Persistence Workshop 2017,
Abstract OP 8.6

Measurement for viral reservoir and immune
function in HIV-1+ patients under antiretroviral therapy

NCT04068441

National Taiwan University Hospital

N/A

JAIDS. 2021 Apr
1;86(4):500-508

MUCOVIR: Exploration of HIV reservoirs

NCT01019044

Objectif Recherche Vaccins SIDA

N/A

JAIDS. 2013 Mar
1;62(3):255–9

PembroHIV: Treatment with immunological
checkpoint inhibitors of HIV+ individuals with cancer

NCT03767465

IrsiCaixa

N/A

HIV Persistence Workshop 2019, Abstract PP
4.2 (see
abstract book)

PITCH:
Prospective interruption of therapy towards a cure for HIV pilot study

NHS Health Research
Authority approval
(not entered into any online registry)

University of Oxford

N/A

CROI 2022, Abstract 266
BHIVA Digital Conference, Nov 22–24, 2020,
Abstract P22

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

NCT02154035

NIAID

N/A

EBioMedicine.
105040.

Virus Evol. 2023 Jul 27;9(2):vead046.
JCI Insight. 2020 Jun
16;139287.

CROI 2020,
Abstract 385
HIV Persistence Workshop 2019,
Abstract OP 7.4
Clin Infect Dis. 2017
Oct 15;65(8):1308-1315.

Role of anti-Tat immunity on disease
progression in HIV+ asymptomatic adults

NCT01029548

National HIV/AIDS Research Center
(CNAIDS), Istituto Superiore di Sanità,
Rome, Italy

N/A

Retrovirology. 2014
Jun 24;11:49.

Role of anti-Tat immunity on disease
progression in HIV+ cART-treated adults

NCT01024556

CNAIDS, Istituto Superiore di Sanità, Rome, Italy

N/A

EBioMedicine 00
(2021) 103306

Seroprevalence of anti-Tat antibodies in
HIV-infected South African patients

NCT01359800

CNAIDS, Istituto Superiore di Sanità, Rome, Italy

N/A

N/A

Size of the HIV-1 reservoir and ongoing
replication in defined cohorts

UK CPMS16004 (link currently broken)

University College London/amfAR

N/A

N/A

Specimen repository for HIV
immunopathogenesis

NCT03579381

AIDS Healthcare Foundation

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

PROTEASOME INHIBITORS

ixazomib

NCT02946047

Mayo Clinic

Phase I

EClinicalMedicine
2021 Nov 29;42:101225.

STEM CELL TRANSPLANTATION

HIVECT: HIV
eradication through cord-blood transplantation

NCT02923076

Puerta de Hierro University
Hospital

N/A

N/A

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

Cell. 2023 Mar
16;186(6):1115-1126.e8.

CROI 2022,
Abstract 65
ASH 2018,
Abstract 2184

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

NCT01410344

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

Phase II

Biol Blood Marrow
Transplant. 2019 Jul 4. pii: S1083-8791(19)30417-3.

J Clin Oncol. 35, no.
15_suppl (May 2017) 7006-7006.

HLA-mismatched unrelated donor bone marrow
transplantation

NCT02793544

Center for International Blood and Marrow
Transplant Research

Phase II

HRSA Advisory Council
on Blood Stem Cell Transplantation
, September 25, 2020

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

NCT00968630

Fred Hutchinson Cancer Research Center

Phase II

N/A

Optimized antiretroviral therapy during
allogeneic hematopoietic stem cell transplantation in HIV-1 individuals

NCT01836068

Sidney Kimmel Comprehensive Cancer Center at
Johns Hopkins

Phase I

JAIDS 2021 Nov 8.
AIDS Res Hum
Retroviruses. 2021 Jun 9.

Lancet HIV. 2020 Jul
7:S2352-3018(20)30073-4.

STIMULANTS

EMRLHD: Effect of methamphetamine on residual
latent HIV disease study

NCT03825536

University of California, San Francisco

Phase IV

N/A

T-CELL RECEPTOR-BASED BISPECIFICS

IMC-M113V in
HLA-A*02:01 positive people

IMC-M113V-101

Immunocore

Phase I/II

CROI 2023, Abstract 436

THERAPEUTIC VACCINES

AGS-004
(personalized therapeutic vaccine utilizing patient-derived dendritic cells
and HIV antigens)

NCT00672191

Argos Therapeutics

Phase IIb

JAIDS. 2016 May
1;72(1):31-8

AGS-004

NCT01069809

Argos Therapeutics

Phase IIb

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

CROI 2014, Poster abstract 344

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

NCT02888756

Rob Gruters, Erasmus Medical
Center

Phase IIa

Vaccines (Basel). 2019 Dec 6;7(4). pii: E209.

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

GTU-multiHIV +
LIPO-5
(DNA + lipopeptide vaccines)

NCT01492985

Inserm-ANRS

Phase II

 

J Virol. 2021 May;
95(9): e02165-20.

J Infect Dis. 2019
Jul 2;220:S5-S6

AIDS. 2018 Oct 15 HIVR4P 2016, Abstract
P27.09

Tat protein vaccine

NCT01513135
NCT02712489 (extended follow-up
study)

CNAIDS, Istituto Superiore di Sanità, Rome, Italy

Phase II

Retrovirology. 2016
Jun 9;13(1):34

Tat protein vaccine

NCT00751595
NCT02118168 (extended follow-up
study)

Barbara Ensoli, MD, Istituto Superiore di
Sanità

Phase II

Front. Immunol.
February 13, 2019

Retrovirology. 2015
Apr 29;12(1):33

PLoS One. 2010 Nov
11;5(11):e13540

Vacc-4x (peptide-based
vaccine)

NCT01712256

Bionor Immuno AS

Phase II

PLoS One. 2019 Jan
30;14(1):e0210965.

Vacc-4x

NCT00659789

Bionor Immuno AS

Phase II

Lancet Infect Dis.
2014 Apr;14(4):291-300

VAC-3S
(peptide-based vaccine)

NCT02041247

InnaVirVax

Phase II

NPJ Vaccines (2019)
4:1

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

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. Cellular
Immunotherapy xx (2016) 1-10

J Int AIDS Soc. 2014
Jan 10;17:18938

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

Front Immunol. 2019
Dec 13;10:2911.

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

NCT03560258

NIAID

Phase I/II

AIDS. 2023 Dec 4.

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

NCT03606213

Steven Deeks, UCSF

Phase I/II

CROI 2023, Abstracts 408, 428
HIV Persistence Workshop 2022,
Abstract PP 8.3
CROI 2022,
Abstract 284

Tat Oyi (protein-based
vaccine)

NCT01793818

Biosantech

Phase I/II

Retrovirology. 2016
Apr 1;13:21

THV01
(lentiviral vector-based therapeutic vaccine)

NCT02054286

Theravectys S.A.

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

JAIDS April
2018;77:57

BMC Infect Dis. 2017
Mar 24;17(1):228.

Ad26.Mos4.HIV +
MVA-Mosaic
or clade C gp140 + mosaic gp140 (viral vector
vaccines + proteins)

NCT03307915

Janssen Vaccines & Prevention B.V.

Phase I

N/A

Ad26.Mos.HIV +
MVA-Mosaic

NCT02919306

Janssen Vaccines & Prevention B.V.

Phase I

HIV Persistence Workshop 2022, Abstract PP 8.6
Nat Med March 23,
2020.

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

ChAdOx1.HTI,
MVA.HTI
, ConM SOSIP.v7 gp140

NCT05208125

IrsiCaixa

Phase I

N/A

ChAdV63.HIVconsv + MVA.HIVconsv
(viral vector vaccines)

NCT01712425

IrsiCaixa/Fundació Lluita contra la
SIDA/Hospital Clinic of Barcelona/ HIVACAT/University of Oxford

Phase I

EClinicalMedicine.
2019 Jun 5;11:65-80.

IAS 2015,
Poster abstract
MOPEA036

Dendritic
cells loaded with HIV-1 lipopeptides

NCT00796770

Baylor Research Institute/ANRS

Phase I

PLoS Pathog. 2019
15(9):e1008011.

Eur J Immunol. 2014
Sep;44(9):2802-10.

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

DNA.HTI +
MVA.HTI + ChAdOx1.HTI
(DNA + viral vector vaccines)
(ATI extension)

NCT04385875

Fundacio Lluita Contra la SIDA

Phase I

N/A

DNA.HTI +
MVA.HTI + ChAdOx1.HTI
(DNA + viral vector vaccines)

NCT03204617

Aelix Therapeutics

Phase I

HIV Persistence Workshop 2022, Abstract OP 8.3 (slides)
Nat Med. 2022 Oct 27.

CROI 2021,
Abstract 161, Webcast

HIVAX
(lentiviral vector-based therapeutic vaccine)

NCT01428596

GeneCure Biotechnologies

Phase I

Vaccine.
2020;S0264-410X(20)30485-0

Vaccine.
2016;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

AIDS. 2018 Nov
13;32(17):2533–2545.

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

JAIDS. 2016 Feb
1;71(2):163-71.

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

NCT01859325

NIAID/Profectus Biosciences, Inc.

Phase I

J. Virology May 20,
2020

CROI 2019,
Poster abstract 392
Sci Transl Med. 2017
Dec 6;9(419). pii: eaan8848

MVA.HIVconsv

NCT01024842

University of Oxford/Medical Research Council

Phase I

J Int AIDS Soc. 2017
May 19;20(1):21171.

MVA.tHIVconsv3
+/- MVA.tHIVconsv4 (viral vectors)

NCT03844386

University of North Carolina, Chapel Hill

Phase I

Results posted in
clinicaltrials.gov

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

China CDC

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

Tat protein vaccine

NCT00505401 NCT01024595 (extended follow-up
study)

CNAIDS, Istituto Superiore di Sanità, Rome, Italy

Phase I

 

Rev Recent Clin Trials. 2009 Sep;4(3):195-204

Vaccine. 2009 May
26;27(25-26):3306-12

AIDS. 2008 Oct
18;22(16):2207-9

TOLL-LIKE RECEPTOR AGONISTS

MGN1703 toll-like receptor 9 (TLR9) agonist

NCT02443935

University of Aarhus

Phase Ib/IIa

EBioMedicine. 2019
Jul 9. pii: S2352-3964(19)30440-2.

AIDS. 2019 Mar 29
Clin Infect Dis. 2017
Mar 9

Poly-ICLC (TLR3 agonist)

NCT02071095

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

Phase I/II

Front Immunol. 2019
Apr 9;10:725.

vesatolimod (TLR7
agonist) in ART-treated HIV controllers

NCT03060447

Gilead Sciences

Phase Ib

Strategies for an HIV
Cure 2023, Abstract PP24

CROI 2023,
Abstract 437
EACS 2021
,
Abstract PE2/1
IAS 2021,
Abstract OAA0304 (video)
Sci Transl Med. 2021
Jun 23;13(599): eabg3071.

CROI 2020, Abstract 40, Webcast

vesatolimod (formerly GS-9620) (TLR7 agonist)

NCT02858401

Gilead Sciences

Phase Ib

CROI 2024, Abstract
542

CID, ciaa1534
IAS 2019,
Abstract WEAA0304 (slides)

vesatolimod
(TLR7 agonist drug interaction study)

NCT05458102

Gilead Sciences

Phase I

Terminated: Sponsor decision to change the
clinical development plan (not based on efficacy or safety concerns)

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
multi
drug 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

Antiretroviral regime for viral eradication
in newborns

NCT02712801

National Center for Women and Children’s
Health, China CDC

Phase IV

N/A

DIORR: Dolutegravir impact on residual replication

NCT02500446

University of Melbourne

Phase IV

The Lancet HIV, April
8, 2018

CROI 2018, Abstract 71, Webcast

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

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

NCT02431975

Columbia University

Phase IV

PLoS Pathog.
2022;18(8):e1010751

Clinical Infectious
Diseases, ciab586

J Clin Med. 2021 May
12;10(10):2074.

EClinicalMedicine 18
(2020) 100241

P25-INACTION:
Implication for strategies of long term control of viral replication in
patients with primary HIV infection

NCT04225325

Adriano Lazzarin, MD

Phase IV

J Med Virol. 2023
Sep;95(9):e29114.

EACS 2021, Abstract BPD4/3

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

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

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

NCT02987530

Inserm/ANRS

Phase III

N/A

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

N/A

Intense acute infection study

NCT01154673

University of Toronto

Phase II/III

N/A

EDIT: Effect of dolutegravir intensification on
HIV-1 reservoirs

NCT05351684

University of Liege

Phase II

N/A

maraviroc

NCT00795444

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

Phase II

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

PLoS One. 2011;
6(12):e27864

peginterferon alfa-2a (Pegasys)

NCT00594880

Wistar Institute

Phase II

EBioMedicine. 2020 Aug 19;59:102945.
J Infect Dis. 2013
Jan 15; 207(2): 213–222

peginterferon alfa-2b

NCT01935089

University of Pennsylvania/Wistar
Institute

Phase II

AIDS Res Hum
Retroviruses. 2020 Dec 15.

CROI 2017,
Poster abstract 326

peginterferon alfa-2b

NCT02227277

Wistar Institute

Phase II

HIV Persistence Workshop 2019,
Abstract PP 4.1 (see
abstract book)
CROI 2019,
Abstract 136, Webcast

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

Nat Med. 2018
Jul;24(7):923-926.

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

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