Research Toward a Cure 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 2024

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

NCT03485963
(closed
to enrollment)

Children’s Research Institute

Phase I

December 2023

ANALYTICAL TREATMENT INTERRUPTION

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

NCT05482854
(not yet open for enrollment)

ANRS

N/A

April 2025

SCOPE-ATI

NCT04359186

UCSF

N/A

June 2024

Imaging and biopsy of HIV+
individuals undergoing ATI

NCT05419024

National Cancer Institute (NCI)

Phase II

August 2026
Front Med. 2022 Aug
22;9:979756.

ANTIBODIES

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

NCT04860323

HIV Vaccine Trials Network

N/A

August 2023

VRC01 (analytical treatment interruption in AMP trial participants)

NCT04801758

HIV Vaccine Trials Network

N/A

January 2030

GSK3810109A (broadly neutralizing
antibody formerly named N6-LS)

NCT04871113
(closed
to enrollment)

ViiV Healthcare

Phase IIa

September 2023
CROI 2023, Abstract
520
HIV Glasgow 2022, Abstract O34

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

NCT04319367

Imperial College London

Phase II

March 2025
HIV Persistence Workshop 2022, Abstracts OP 7.2, PP
8.11
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

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

vedolizumab (anti-α₄β₇ integrin
antibody)

NCT03147859

Ottawa Hospital Research
Institute

Phase II

December 2021
BMJ Open. 2020; 10(10):e041359.
CROI 2019, Abstract 393, Webcast

VRC07-523LS + PGT121.414.LS

NCT05719441
(not yet open for enrollment)

NIAID

Phase II

September 2028

ABBV-382 (anti-α₄β₇ integrin antibody)

NCT04554966

AbbVie

Phase Ib

July 2023

3BNC117-LS + 10-1074-LS

NCT05612178

NIAID

Phase I

December 2025

3BNC117-LS + 10-1074-LS

NCT05079451
(suspended)

NIAID

Phase I

February 2024

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

NCT03374202
(closed
to enrollment)

NIAID

Phase I

August 2026
Nat Med. 2022 Apr 11

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

SAR441236 (tri-specific broadly neutralizing antibody)

NCT03705169

NIAID

Phase I

November 2023

ANTI-CMV THERAPY

letermovir (Prevymis)

NCT04840199

(suspended)

NIAID

Phase II

May 2025

ANTI-INFLAMMATORY

canakinumab (IL-1β inhibitor)

NCT02272946
(closed
to enrollment)

University of California, San Francisco

Phase II

December 2022
J Am Coll Cardiol.
72(22):2809-2811.
CROI 2017, Abstract 126, Webcast

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

October 2024

CANNABINOIDS

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

NCT05306249

Centre Hospitalier Régional d’Orléans

Phase II

February 2023

COMBINATIONS

VRC07-523LS, CAP256V2LS, vesatolimod

NCT05281510

Gilead Sciences

Phase IIa

February 2024

Albuvirtide (fusion inhibitor) + 3BNC117

NCT04819347
(not yet open for enrollment)

Frontier Biotechnologies Inc.

Phase II

December 2022

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

NCT05129189

Shanghai Public Health Clinical Center

Phase II

July 2023

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

NCT02336074
UK CPMS18010
(closed
to enrollment)

Imperial College London

Phase II

November 2022
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 (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 2026

UB-421 + chidamide

NCT05056974

United BioPharma

Phase II

December 2023

vorinostat +/- tamoxifen
in postmenopausal women

NCT03382834
(closed
to enrollment)

NIAID

Phase II

June 2023
Clin Infect Dis. 2022
Feb 17:ciac136.
CROI 2020, Abstract 333, Webcast
HIV Persistence Workshop 2019, Abstract OP 3.2 (see abstract book)

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

NCT04983030

Boris Juelg, MD PhD

Phase I/IIa

March 2024

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 2022, Abstract 31

panobinostat + pegylated
interferon-alpha2a

NCT02471430
(closed
to enrollment)

Massachusetts General Hospital

Phase I/II

January 2023
CROI 2022, Abstract 357
CROI 2020, Abstract 341

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

NCT04357821
(closed to enrollment)

UCSF

Phase I/II

December 2024
CROI 2023, Abstract
435

FT538 +/- vorinostat

NCT05700630
(not yet open for enrollment)

Masonic Cancer Center, University of
Minnesota

Phase I

August 2023

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

NCT04301154

PENTA Foundation

Phase I

October 2023

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

NCT04340596

NIAID

Phase I

November 2024

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

NCT05245292

Rockefeller University

Phase I

December 2025

VRC07-523LS,
PGDM1400LS, N-803, Ad26.Mos4.HIV, MVA-Bavarian Nordic (BN)-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

August 2022

DUAL-AFFINITY RE-TARGETING (DART) MOLECULES

MGD020 +/- MGD014

NCT05261191

MacroGenics

Phase I

July 2023

GENE THERAPIES

EBT-101 (CRISPR/Cas9
targeting HIV provirus)

NCT05144386

Excision BioTherapeutics

Phase I/IIa

March 2025

LVgp120duoCAR-T cells

NCT04648046

Steven Deeks, UCSF

Phase I/IIa

December 2025

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

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

NCT04561258

American Gene Technologies International Inc.

Phase I

September 2022
Front Med 2022
9:1044713.

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

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
J Clin Invest. 2021 Aug 10;150211.

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

NCT05143307
(enrolling by invitation)

Excision BioTherapeutics

Phase I

April 2037

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

NCT04201782
(enrolling by invitation)

Sangamo Therapeutics

Phase I

June 2035

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

December 2023

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

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

NCT02797470

AIDS Malignancy Consortium

Phase I/II

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 2023

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 2022

GONADOTROPIN-RELEASING HORMONE (GnRH) AGONISTS

triptorelin acetate depot

NCT03536234
(closed
to enrollment)

Immune System Regulation AB

Phase II

March 2023

IMAGING STUDIES

Imaging immune activation in HIV by PET-MR

NCT03684655

University of California, San Francisco

Phase I

October 2024

Radiolabeled VRC01

NCT03729752

University of California, San Francisco

Phase I

October 2021
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

March 2023

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

NCT05187429

University of Melbourne

Phase I/II

January 2024

budigalimab (anti-PD-1
antibody)

NCT04223804
(closed to enrollment)

AbbVie

Phase Ib

April 2023

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
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

National Cancer Institute (NCI)

Phase I

November
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

pembrolizumab (anti-PD-1 antibody) single dose

NCT03239899

National Institute of Neurological Disorders
and Stroke (NINDS)

Phase I

December 2024
HIV Persistence Workshop 2022, Abstract OP 1.10

IMMUNOMODULATORS

lenalidomide, adenosylmethionine

NCT05598580
(not yet
open for enrollment)

First Affiliated Hospital of
Zhejiang University

Phase IV

November 2024

JANUS KINASE INHIBITORS

baricitinib

NCT05452564
(not yet open for enrollment)

Emory University

Phase II

November 2027

LATENCY-REVERSING AGENTS

lauric acid

NCT05687565

Hospital Universitari Vall d’Hebron Research
Institute

N/A

December 2025

arsenic trioxide

NCT03980665

Guangzhou 8th People’s Hospital

Phase I

December 2025

decitabine, romidepsin

NCT05230368

ANRS

Phase I

April 2026

Euphorbia kansui

NCT04503928
(not yet open for enrollment)

Shanghai Public Health Clinical Center

Phase I

December 2022

Kansui (traditional Chinese medicine containing ingenols)

NCT02531295
(Suspended
– temporary pause on non-COVID clinical trial recruitment at study site)

UCSF

Phase I

June 2023

mTOR INHIBITORS

metformin

NCT04500678

University of Hawaii

Phase II/III

December 2022
AIDS Res Hum
Retroviruses. 2020 Nov 5.

STEM CELL TRANSPLANTATION

IMPAACT P1107: Cord blood
transplantation using CCR5-Δ32 donor cells for the treatment of HIV and underlying disease

NCT02140944

(closed to enrollment)

International Maternal Pediatric Adolescent
AIDS Clinical Trials Group (IMPAACT)

N/A

November 2022
CROI 2022, Abstract 65
ASH 2018, Abstract 2184

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

NCT04083170

Fred Hutchinson Cancer Research Center

Phase II

December 2025

STIMULANTS

EMRLHD: Effect of methamphetamine on residual
latent HIV disease study

NCT03825536

University of California, San Francisco

Phase IV

June 2023

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

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

ChAdOx1.HIVconsv62–MVA.tHIVconsv4
(C62-M4), ChAdOx1.tHIVconsv1+C62-MVA.tHIVconsv3+M4
(C1C62-M3m4)

NCT05604209

University of North Carolina, Chapel Hill

Phase I

August 2024

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

NCT05208125

IrsiCaixa

Phase I

March 2023

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

NCT03758625

Sharon Riddler, University of Pittsburgh

Phase I

June 2024

NETI: Trimer 4571 therapeutic vaccination

NCT04985760

NIAID

Phase I

January 2025

TOLL-LIKE RECEPTOR AGONISTS

vesatolimod
(TLR7 agonist drug interaction study)

NCT05458102

Gilead Sciences

Phase I

May 2023

TREATMENT INTENSIFICATION/EARLY TREATMENT

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

NCT02656511
(closed
to enrollment)

UCSF

Phase IV

April 2023

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

(not yet open for enrollment)

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

Phase II

December 2024

Trial

Trial Registry Identifier(s)

Manufacturer/
Sponsor(s)

Phase

Estimated End Date/Interim
Results

2000HIV: 2000 HIV human functional genomics partnership
program

NCT03994835
(closed
to enrollment)

Radboud University

N/A

January 2026
Front Immunol. 2022
Dec 20;13:982746

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

NCT04968717
(closed
to enrollment)

Radboud University

N/A

December 2022
CROI 2023, Abstracts 313,
314

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
(not yet open for enrollment)

University Hospital,
Strasbourg, France

N/A

February 2027

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 2029

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
CROI 2023, Abstract
387

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

NCT04888754

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 2024

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

DOLUVOIR: Cartography of virologic reservoir
related to antiretroviral concentrations in HIV-1+ patients on first line
treatment containing dolutegravir and associated nucleoside/nucleotide
reverse transcriptase inhibitors backbone

NCT04133012

Inserm-ANRS

N/A

November 2023

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

Barbara Ensoli, MD, PhD, Istituto Superiore
di Sanità

N/A

December 2023

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

NCT05680948
(not yet open for enrollment)

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

FXR#2: Selection of farnesoid X receptor (FXR)
ligands on the reactivation of latent HIV proviruses

NCT05219916
(not yet open for enrollment)

Hospices Civils de Lyon

N/A

September 2024

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
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.

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

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 2023

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
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 use of leukapheresis to support HIV
pathogenesis studies

NCT01161199

University of California, San Francisco

N/A

December 2022

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

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.

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-α₄β₇
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

N/A

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

CROI 2023,
Abstracts 141, 828
JAIDS. 2022 Oct
1;91(2):182-188.
CROI 2022, Abstract 32
CROI 2021, Abstract 609, Webcast

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

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

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
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

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

NCT02840474

NIAID

Phase I

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

ANTI-FIBROTIC

ACE inhibitors

NCT01535235

UCSF/amfAR

Phase IV

Pathogens and
Immunity. 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

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

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

Open Forum Infect
Dis. 2019 Jun 3;6(6):ofz246.
AIDS 2018, Poster abstract
LBPEB021

ANTI-PROLIFERATIVE

mycophenolate mofetil (MMF)

NCT03262441

Fred Hutchinson Cancer Research Ctr

Phase I

Open Forum Infect Dis
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

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

TN-TC11M2, TN-C200M2 oral capsules

NCT03550352

McGill University Health Center

Phase II

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. 2019 Aug 5. 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

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

N/A

eCLEAR: romidepsin + 3BNC117

NCT03041012

Aarhus University Hospital

Phase II

HIV Persistence Workshop 2022, Abstract OP 1.9
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-α₄β₇ integrin antibody)

NCT04120415

ANRS

Phase II

Stopped due to logistical issues

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-α₄β₇ integrin antibody)

NCT02972450

Inserm-ANRS

Phase I/II

Terminated due to bankruptcy of FITBiotech

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

N/A

AGS-004 + vorinostat

NCT02707900

NIAID

Phase I

Sci Rep. 2020 Mar
20;10(1):5134.
IAS 2019, Poster abstract
MOPEB272

CD4-ZETA gene–modified 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.

J Antimicrob
Chemother. 2015 Feb 26. pii: dkv046.

MVA.HIVconsv
+ romidepsin

NCT02616874

IrsiCaixa

Phase I

CROI 2023,
Abstracts 385, 481
Microbiome. 2022 Apr
11;10(1):59.
EBioMedicine. 2022
Mar 21;78:103956.
AIDS. 2021 Nov 3
J Antimicrob
Chemother. 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 2023,
Abstracts 319,
326,
384,
431
HIV Persistence Workshop 2022, Abstracts PP 7.2, PP
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

N/A

VRC07-523LS + vorinostat

NCT03803605

University of North Carolina, Chapel Hill

Phase I

J Infect Dis. 2021
Sep 25: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

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
2021.02.28.433290
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

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

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
2021.02.28.433290
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.

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

J Acquir Immune Defic
Syndr. 87(5):e234-e236.
Pre-CROI Community HIV Cure Research Workshop 2020 (slides, video)
ACTG announcement

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

N/A

ipilimumab (anti-CTLA-4 antibody)

NCT03407105

Medarex

Phase I

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

IRON CHELATORS

deferiprone

NCT02456558

ApoPharma

Phase I

N/A

JANUS KINASE INHIBITORS

ruxolitinib

NCT02475655

NIAID

Phase II

J Clin Pharmacol.
2021 Jun 24.
Clin Infect Dis. 2021
ciab212
CROI 2019, Abstract 37, Webcast

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

N/A

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.

mTOR INHIBITORS

Impact of Everolimus on HIV
persistence post kidney or liver transplant

NCT02429869

UCSF

Phase IV

Am J Transplant. 2020
Aug 11

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

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 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 &
380

N/A

CROI 2023, Abstracts
337, 380
HIV Persistence Workshop 2022, Abstracts OP 7.3, PP
7.9
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)

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: December 02,
2019

Clin Infect Dis. 2019
Mar 28. pii: ciz251
AIDS
2014, Abstract TUAB0206LB (video)
Clin Infect Dis.
(2014) 59 (7): 1012-1019.

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

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, Department of Laboratory Medicine, 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

J Acquir Immune Defic
Syndr. 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

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