Research Toward a Cure Trials

Trial

Trial Registry Identifier(s)

Sponsor(s)

Phase

Estimated End Date/Interim
Results

ADOPTIVE IMMUNOTHERAPY

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

NCT04248192
(not yet open for enrollment)

Catherine Bollard, Children’s
Research Institute

Phase I

April 2024

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

NCT03485963

Children’s Research Institute

Phase I

December 2021

ANTIBODIES

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

NCT04319367
(not yet open for enrollment)

Imperial College London

Phase II

October 2024

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 2024

UB-421

NCT03743376
(closed to enrollment)

United BioPharma

Phase II

December 2021

vedolizumab (anti-α₄β₇ integrin
antibody)

NCT03147859

Ottawa Hospital Research
Institute

Phase II

December 2021
CROI 2019 Abstract 393, Webcast

PGT121 + VRC07-523LS +/- PGDM1400

NCT03721510

International AIDS Vaccine Initiative

Phase I/IIa

November 2020

VRC01 (broadly neutralizing antibody) in
infants

NCT03208231
(closed
to enrollment)

NIAID

Phase I/II

February 2021

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

NCT03707977

NIAID

Phase I/II

October 2021

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

NCT03554408
(closed
to enrollment)

Rockefeller University

Phase I

June 2021

3BNC117 + 10-1074
(broadly neutralizing antibodies)

NCT03571204

NIAID

Phase I

June 2021

3BNC117 + 10-1074

NCT03526848

Rockefeller University

Phase I

April 2022

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

NCT04250636

Rockefeller University

Phase I

February 2022

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

NCT03374202

NIAID

Phase I

March 2020
CROI 2020, Abstract 41LB, Webcast

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

GS-US-420-3902 Adisinsight entry (not listed in
clinicaltrials.gov)

Gilead Sciences

Phase I

N/A
CROI 2020, Abstract 39, Webcast

SAR441236 (tri-specific broadly neutralizing antibody)

NCT03705169

NIAID

Phase I

February 2022

VRC01 in acute HIV infection

NCT02591420

NIAID

Phase I

March 2021

ANTI-INFLAMMATORY

canakinumab (IL-1β inhibitor)

NCT02272946

University of California, San Francisco

Phase II

December 2022
J Am Coll Cardiol.
2018 Dec 4;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

October 2023

ANTIRETROVIRAL THERAPY

doravirine concentrations and antiviral
activity in cerebrospinal fluid

NCT04079452
(not yet open for enrollment)

Fundacio Lluita Contra la SIDA

Phase III

October 2020

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

NCT04034862
(not yet
open for enrollment)

University of Liege

Phase III

March 2022

CANNABINOIDS

TN-CT11LM, TN-TC19LM oral capsules

NCT03550352
(not
yet open for enrollment)

McGill University Health Center

Phase II

December 2019

COMBINATIONS

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

NCT02707692
(closed
to enrollment)

University of California, San Diego

Not listed

January 2021

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

NCT04364035

Aelix Therapeutics

Phase IIa

December 2022

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

NCT03837756

University of Aarhus

Phase IIa

February 2021

eCLEAR: romidepsin + 3BNC117

NCT03041012
(closed
to enrollment)

Aarhus University Hospital

Phase II

June 2021

MVA HIV-B +/- vedolizumab (viral
vector vaccine +/- anti-α₄β₇ integrin antibody)

NCT04120415
(not yet open for enrollment)

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

Phase II

December 2022

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
Lancet. 2020 Mar
14;395(10227):888-898
AIDS 2018, Abstract TUAA0202LB (slides, video)

vorinostat +/- tamoxifen
in postmenopausal women

NCT03382834
(closed
to enrollment)

NIAID

Phase II

June 2023
CROI 2020, Abstract 333, Webcast
HIV Persistence Workshop 2019, Abstract OP 3.2 (see abstract book)

HIVARNA01.3, MVA
vector HIV vaccine, 10-1074, romidepsin, HIVACAR01 (personalized HIV RNA vaccine)

NCT03619278
(not yet open for enrollment)

David Garcia Cinca

Phase I/IIa

July 2021

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

panobinostat + pegylated interferon-alpha2a

NCT02471430

Massachusetts General Hospital

Phase I/II

December 2020
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

UCSF

Phase I/II

December 2024

Adoptive transfer of haploidentical
NK cells and N-803

NCT03899480

University of Minnesota – Clinical and
Translational Science Institute

Phase I

November 2020

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

NCT01013415
(closed to enrollment)

University of Pennsylvania

Phase I

December 2021
CROI 2020, Abstract 337, Webcast
Mol Ther. 2002
Jun;5(6):788-97

Chidamide + CAR-T or TCR-T cell therapy

NCT03980691

Guangzhou 8th People’s Hospital

Phase I

December 2021

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

NCT04301154
(not yet open for enrollment)

PENTA Foundation

Phase I

September 2021

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

NCT04340596
(not yet open for enrollment)

NIAID

Phase I

June 2023

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

NCT03588715

Wistar Institute

Phase I

June 2022

VRC07-523LS + vorinostat

NCT03803605

University of North Carolina, Chapel Hill

Phase I

July 2022

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

NCT03212989

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

Phase I

June 2021

CYTOKINES

N-803 in acute
HIV infection

NCT04505501
(not yet
open for enrollment)

Thai Red Cross AIDS Research Centre

Phase II

August 2022

DUAL-AFFINITY RE-TARGETING (DART) MOLECULES

MGD014

NCT03570918

MacroGenics

Phase I

October 2021

GENE THERAPIES

LVgp120duoCAR-T cells

NCT04648046
(not yet open for enrollment)

Steven Deeks, UCSF

Phase I/IIa

December 2024

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

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

CD4 CAR + SB-728mR modified
T cells

NCT03617198

University of Pennsylvania

Phase I

December 2025

Chimeric Antigen Receptor (CAR)-T cell
therapy

NCT03240328

Guangzhou 8th People’s Hospital

Phase I

December 2021

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

NCT04201782
(enrolling by invitation only)

Sangamo Therapeutics

Phase I

December 2031

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

NCT02500849
(closed to enrollment)

City of Hope Medical Center

Phase I

March 2021

shRNA-modified CD34+ cells

NCT03517631

Shanghai Public Health Clinical Center

Phase I

December 2020

Anti-gp120 CAR-T cells (autologous T cells agene-modified to express a chimeric antigen receptor targeting HIV gp120)

ChiCTR-OPN-17013068
(not
yet open for enrollment)

Jinyintan Hospital of WuHan

Phase 0

December 2018

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

May 2021
N Engl J Med. 2019
Sep 11

Stem cells gene-modified with Cal-1

NCT03593187

Assistance Publique – Hôpitaux de
Paris

Phase I/II

January 2024
Mol Ther Methods Clin
Dev. 2019 Feb 26;13:303-309

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

NCT02797470

AIDS Malignancy Consortium

Phase I/II

June 2036

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

NCT02337985
(closed to enrollment)

City of Hope Medical Center

Phase I

June 2022

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 2021

GONADOTROPIN-RELEASING HORMONE (GnRH) AGONISTS

triptorelin acetate depot

NCT03536234

Immune System Regulation AB

Phase II

December 2021

HORMONES

somatotropin (human growth
hormone)

NCT03091374

McGill University Health Center

Phase II

December 2020

IMAGING STUDIES

Imaging immune activation in HIV by PET-MR

NCT03684655

University of California, San Francisco

Phase I

June 2021

Radiolabeled VRC01

NCT03729752

University of California, San Francisco

Phase I

October 2020
CROI 2020, Abstract 72, Webcast

IMMUNE CHECKPOINT INHIBITORS

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

NCT03094286
(closed
to enrollment)

Spanish Lung Cancer Group

Phase II

April 2022
Journal of Clinical
Oncology 37, no. 15_suppl (May 20, 2019) 2501-2501.

budigalimab (anti-PD-1
antibody)

NCT04223804

AbbVie

Phase Ib

February 2022

nivolumab (anti-PD-1 antibody) +
ipilimumab (anti-CTLA-4 antibody) in treating patients with
advanced HIV associated solid tumors

NCT02408861

National Cancer Institute (NCI)

Phase I

July 2022
HIV Persistence Workshop 2019, Abstract OP 5.5 (see abstract book)
Journal of Clinical
Oncology 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

July
2021
JAMA
Oncol. 2019 Jun 2
CROI 2019, Abstract
27,
Webcast
CROI 2018, Poster
abstract 656LB

pembrolizumab (anti-PD-1 antibody)
single dose

NCT03239899

National Institute of Neurological Disorders
and Stroke (NINDS)

Phase I

December 2021

LATENCY-REVERSING AGENTS

arsenic trioxide

NCT03980665

Guangzhou 8th People’s Hospital

Phase I

December 2021

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

December 2020

mTOR INHIBITORS

metformin

NCT04500678

University of Hawaii

Phase II/III

December 2022
AIDS Res Hum
Retroviruses. 2020 Nov 5.

PROTEASOME INHIBITORS

ixazomib

NCT02946047
(closed
to enrollment)

Mayo Clinic

Phase I

January 2022

STEM CELL TRANSPLANTATION

HIVECT: HIV
eradication through cord-blood transplantation

NCT02923076

Puerta de Hierro University
Hospital

N/A

December 2018

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

NCT02140944

(closed to enrollment)

International Maternal Pediatric Adolescent
AIDS Clinical Trials Group (IMPAACT)

N/A

March 2023
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 2022

STIMULANTS

EMRLHD: Effect of methamphetamine on residual
latent HIV disease study

NCT03825536

University of California, San Francisco

Phase IV

June 2022

THERAPEUTIC VACCINES

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

NCT03560258
(closed
to enrollment)

NIAID

Phase I/II

February 2021

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

NCT03606213
(closed to enrollment)

Steven Deeks, UCSF

Phase I/II

December 2022

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

NCT03307915
(closed
to enrollment)

Janssen Vaccines & Prevention B.V.

Phase I

November 2021

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

NCT03758625

Sharon Riddler, University of Pittsburgh

Phase I

May 2022

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

NCT04385875
(closed to enrollment)

Fundacio Lluita Contra la SIDA

Phase I

June 2022

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

NCT03204617
(closed to enrollment)

Aelix Therapeutics

Phase I

March 2021

MVA.tHIVconsv3
+/- MVA.tHIVconsv4 (viral vector vaccines)

NCT03844386

University of North Carolina, Chapel Hill

Phase I

July 2021

TREATMENT INTENSIFICATION/EARLY TREATMENT

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

NCT04225325

Adriano Lazzarin, MD

Phase IV

June 2021

Antiretroviral regime for viral eradication
in newborns

NCT02712801

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

Phase IV

December 2020

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

NCT02656511

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

Harvard School of Public Health

Phase II/III

May 2021
Clin Infect Dis. 2020
Jan 12. [Epub ahead of print]
Sci Transl Med. 2019
Nov 27;11(520). pii: eaax7350
CROI
2019, Poster abstract 826
CROI
2018, Abstract 136, Webcast

EARLIER: Early ART to limit infection and
establishment of reservoir

NCT02859558
(closed
to enrollment)

AIDS Clinical Trials Group

Phase II

September 2023

Trial

Trial Registry Identifier(s)

Manufacturer/
Sponsor(s)

Phase

Estimated End Date/Interim
Results

2000HIV: 2000 HIV Human Functional Genomics
Partnership Program

NCT03994835

Radboud University

N/A

December 2023

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

NCT03449706

University Hospital, Ghent

N/A

January 2023

Analytic treatment interruption
(ATI) to assess HIV cure

NCT02437526
(enrolling by invitation only)

Mayo Clinic

N/A

May 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

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

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

NCT03001128

AIDS Clinical Trials Group

N/A

January 2021
AIDS 2020, Abstract PDB0102

CODEX (the “Extreme” cohort, ANRS CO21)

NCT01520844

Inserm-ANRS

N/A

September 2023
See supplemental
references page

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

NCT03215004

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

February 2021

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

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

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

NCT03618862

Hospices Civils de Lyon

N/A

July 2021

Genotyping FcɣRs genes

NCT03130296

University Hospital, Strasbourg, France

N/A

February 2020

HEATHER: HIV reservoir targeting with early
antiretroviral therapy

UK CPMS17589

University of Oxford/Medical Research
Council/British HIV Association

N/A

September 2019
J Infect Dis. 2019
Nov 28. pii: jiz563

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

NCT04305665
(not yet
open for enrollment)

University Hospital, Ghent

N/A

December 2025

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

NCT03426189
(closed
to enrollment)

University of Melbourne

N/A

January 2021

Host & viral factors associated with HIV
elite control

UK CPMS16146

University College London Hospitals NHS
Foundation Trust

N/A

May 2021

HSCT-HIV: Allogeneic hematopoietic stem cell
transplantation in HIV-1 infected patients

NCT02732457

Kirby Institute

N/A

September 2024

HUSH restriction in HIV+ patients

NCT04172480

Inserm-ANRS

N/A

September 2022

iCHIP: Effect of immune checkpoint inhibitors on
HIV persistence

hivcure.com.au (no registry entry)

University of Melbourne

N/A

N/A
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

CROI 2020, Abstract 339
CROI 2020, Abstract 348LB
Lancet HIV. 2020 Mar
9.
HIV Persistence Workshop 2019, Abstract OP 4.5 (see abstract book)
Nature. 2019
Apr;568(7751):244-248.
CROI 2019, Poster abstract 394
Ann Intern Med. 2018
Nov 20;169(10):674-683.

Identification and quantification of HIV CNS
latency biomarkers

NCT02989285

St Vincent’s Hospital, Sydney

N/A

December 2020

Impact of ART adherence on HIV persistence
and inflammation

NCT02797093
(closed
to enrollment)

University of Colorado, Denver

N/A

October 2021

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

December 2020

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

NCT04068441

National Taiwan University Hospital

N/A

December 2021

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

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

University of Oxford

N/A

N/A
Abstract P22, BHIVA
Digital Conference, Nov 22–24, 2020

Post analytic treatment interruption study

NCT02761200

South East Asia Research Collaboration with
Hawaii

N/A

March 2021

PRIMO (ANRS CO6): Primary infection cohort

NCT03148964

Inserm-ANRS

N/A

December 2020
See supplemental
references page

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

NCT02154035
(closed
to enrollment)

NIAID

N/A

January 2022
JCI Insight. 2020 Jun
16;139287.
CROI 2020, Abstract 385
HIV Persistence Workshop 2019, Abstract OP 7.4 (see abstract book)
Clin Infect Dis. 2017
Oct 15;65(8):1308-1315.

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

June 2021

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

NCT03622177

Inserm-ANRS

N/A

September 2023

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

NCT04653610
(not yet open for enrollment)

University Hospital, Ghent

N/A

January 2025

SCOPE-ATI: SCOPE analytic treatment interruption protocol

NCT04359186
(enrolling by invitation)

UCSF

N/A

June 2024

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

NCT03117985

Centre Hospitalier Régional
d’Orléans

N/A

September 2022

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
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 2035

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.

ANTIBODIES

CHERUB 001
Intravenous immunoglobulin in primary HIV infection

No clinicaltrials.gov entry

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

N/A

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

3BNC117 (broadly neutralizing monoclonal
antibody)

NCT02446847

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)

NCT02369146

United BioPharma

Phase II

N Engl J Med. 2019
Apr 18;380(16):1535-1545

vedolizumab (anti-α₄β₇
integrin antibody)

NCT03577782

Hospitales Universitarios Virgen del Rocío

Phase II

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

VRC01 (broadly neutralizing monoclonal antibody)

NCT02664415
(also
entered in clinicaltrials.gov as NCT03036709)

National Institute of Allergy and Infectious
Diseases (NIAID)

Phase II

IAS 2017, Abstract TUAB0106LB (slides, video)

10-1074 (broadly neutralizing monoclonal
antibody)

NCT02511990

Rockefeller University

Phase I

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

3BNC117

NCT02018510

Rockefeller University

Phase I

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

3BNC117 + 10-1074

NCT02825797

Rockefeller University

Phase I

Nature. 2018 Sep;561(7724):479-484.
Nat Med. 2018 Sep 26.

3BNC117-LS

NCT03254277

Rockefeller University

Phase I

N/A

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

NCT03205917

International AIDS Vaccine Initiative

Phase I

N/A

PGT121

NCT02960581

International AIDS Vaccine Initiative

Phase I

CROI 2019, Abstract 145, Webcast

vedolizumab

NCT02788175

NIAID

Phase I

AIDS 2018, WESS0102

VRC01 + 10-1074

NCT03831945

NIAID

Phase I

N/A

VRC01

NCT02411539

NIAID

Phase I

N/A

VRC01

NCT02471326

NIAID

Phase I

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

VRC01

NCT02463227

NIAID

Phase I

N Engl J Med. 2016
Nov 24;375(21):2037-2050
CROI 2016, Abstract 32LB, Webcast

VRC01

NCT01950325

NIAID

Phase I

Sci Transl Med. 2015
Dec 23;7(319):319ra206

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

High dose vitamin D supplementation

NCT03426592

University of Melbourne

Phase II

N/A

CC-11050 (phosphodiesterase-4 inhibitor)

NCT02652546

NIAID

Phase I

AIDS 2018, Poster abstract
LBPEB021

ANTI-PROLIFERATIVE

mycophenolate mofetil (MMF)

NCT03262441

Fred Hutchinson Cancer Research Ctr

Phase I

CROI 2020, Abstract 340

ANTIRETROVIRAL THERAPY

dolutegravir in reservoirs

NCT02924389

Emory University

Phase N/A

AIDS. 2018 Jul 12
[Epub ahead of print]

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

NCT02513147

Hospital Universitari Vall d’Hebron Research
Institute

Phase IV

N/A

raltegravir or efavirenz + tenofovir + emtricitibine

NCT00734344

University of Alabama at Birmingham

Phase IV

N/A

ABX464

NCT02735863

Abivax S.A.

Phase II

J. Virus Eradication
2019;5:10–22

ABX464

NCT02990325

Abivax S.A.

Phase I/II

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

16th European Meeting on HIV & Hepatitis
Treatment Strategies & Antiviral Drug Resistance 2018, presentation

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

The Journal of
Infectious Diseases, jiaa635
CROI 2020, Abstract 506
HIV DART 2018

BIT225

ACTRN
12612000696897

Biotron Limited

Phase I

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

COMBINATIONS

maraviroc, dolutegravir, dendritic cell
vaccine, auranofin, nicotinamide

NCT02961829

Federal University of São Paulo

Not listed

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)

ROADMAP: romidepsin
+ 3BNC117

NCT02850016

Rockefeller University

Phase IIa

CROI 2020, Abstract 38, Webcast

Adoptive transfer of haploidentical
natural killer cells and IL-2

NCT03346499

University of Minnesota – Clinical and
Translational Science Institute

Phase II

N/A

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

disulfiram + vorinostat

NCT03198559
(suspended
due to neurotoxicity)

The Peter Doherty Institute for Infection and
Immunity

Phase I/II

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 the bankruptcy of
FITBiotech, the provider of the GTU DNA vaccine

Vacc-4x + romidepsin

NCT02092116

Bionor Immuno AS/Celgene

Phase I/II

CROI 2019, Abstract 397
Lancet HIV 2016, July
7, 2016

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

NCT01704781

Bionor Immuno AS

Phase I/II

IAS 2015 Towards an HIV Cure Symposium, Poster abstract PE61

vorinostat + hydroxychloroquine + maraviroc
(VHM)

NCT02475915
NCT02470351 (CNS substudy)

South East Asia Research Collaboration with
Hawaii

Phase I/II

J Virus Erad. 2020
(6) 100004
AIDS 2016, Abstract TUAX0101LB

AGS-004 + vorinostat

NCT02707900

NIAID

Phase I

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

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

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

NCT02767193

Judit Pich Martínez, Fundació Clínic per la
Recerca Biomèdica

Phase I

CROI 2020, Abstract 282
The Journal of
Infectious Diseases, jiz611

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

J
Antimicrob Chemother. 2020 Dec 22;dkaa523.
Front Immunol. 2020
May 6;11:823.
CROI 2019, Abstract 438
CROI 2017, Abstract 119LB, Webcast

CYTOKINES

interleukin-2 (IL-2)

NCT03308786

Case Western Reserve University

Phase II

N/A

N-803

NCT02191098

University of Minnesota – Clinical and Translational
Science Institute

Phase I

CROI 2018, Poster abstract 356

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

N/A

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 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

Molecular Therapy,
November 10, 2020
CROI 2015, Poster abstract 402

Redirected high affinity Gag-specific T cells

NCT00991224

University of Pennsylvania/Adaptimmune

Phase I

Study closed due to safety concern, see: Mol Ther. 2015 Jul;
23(7): 1149–1159.

SB-728mR-T + cyclophosphamide

NCT02388594

University of Pennsylvania

Phase I

CROI 2019, Abstract 25, Webcast

SB-728-T

NCT01044654

Sangamo BioSciences

Phase I

ICAAC 2014, Abstract H-643; 2013, Abstract H-1464c

SB-728-T

NCT00842634

Sangamo Biosciences/University of Pennsylvania

Phase I

N Engl J Med. 2014
Mar 6;370(10):901–10

GENE THERAPIES FOR HIV-POSITIVE PEOPLE WITH CANCERS

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

NCT00858793

Universitätsklinikum Hamburg-Eppendorf

Phase I/II

N/A

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.

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

AIDS 2020, Abstract PEA0060

IMMUNE CHECKPOINT INHIBITORS

cemiplimab (anti-PD-1 antibody)

NCT03787095

NIAID

Phase I/II

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

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

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/Canadian Foundation for
AIDS Research/CIHR Canadian HIV Trials Network

Phase II

HIV Med. 2012
May;13(5):291–6

valproic acid

NCT00614458

University of North Carolina at Chapel Hill/NIAID/Abbott/Merck
Sharp & Dohme

Phase II

PLoS One. 2010 5(2):
e9390

Chidamide (HDAC inhibitor)

NCT02513901

Tang-Du Hospital

Phase I/II

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 Feb 17.
[Epub ahead of print]

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

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

HIV Persistence Workshop 2019, Abstracts OP
4.6, 5.6 & PP 4.4 (see abstract book)

CROI 2018, Abstract 119, Webcast
Poster abstract 403LB

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

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

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

Clinical Infectious
Diseases, 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
2015 IAS Towards an HIV Cure Symposium, Abstract PE69LB
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).

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

NCT03244371

Assistance Publique Hopitaux De Marseille

N/A

N/A

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

CROI 2020, Abstract 324
Cell Host Microbe.
2019 Sep 11;26(3):347-358.e7.
AIDS 2018, Abstract WEAA0201 (slides, video), poster abstract THPEB096

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 a short-term analytical treatment
interruption 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

LoViReT: Low viral reservoir treated patients

NCT02972931

IrsiCaixa

N/A

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

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)

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

N/A

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

STEM CELL TRANSPLANTATION

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.
Journal of Clinical
Oncology 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

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

THERAPEUTIC VACCINES

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

NCT00672191

Argos Therapeutics

Phase IIb

J Acquir Immune Defic
Syndr. 2016 May 1;72(1):31-8

AGS-004

NCT01069809

Argos Therapeutics

Phase IIb

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

IAS 2015 Towards an HIV Cure Symposium, Combination Therapy
Trials Roundtable

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 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

IAS 2015 Towards an HIV Cure Symposium, Poster abstract PE67
LB

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.

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.Mos.HIV +
MVA-Mosaic

NCT02919306

Janssen Vaccines & Prevention B.V.

Phase I

Nat Med March 23,
2020.
IAS 2019 HIV & HBV Cure Forum, FT5-1 Flash Talk

AFO-18 (peptide-based
vaccine)

NCT01141205

Statens Serum Institut (SSI)/Ministry of the
Interior and Health, Denmark/European and Developing Countries Clinical
Trials Partnership (EDCTP)

Phase I

AIDS Res Hum
Retroviruses. 2013 Nov;29(11):1504-12

AFO-18 (peptide-based
vaccine)

NCT01009762

SSI/Rigshospitalet/Hvidovre University Hosp./Ministry
of Interior & Health, Denmark

Phase I

Clin Immunol. 2013
Feb;146(2):120-30

AT20-KLH

MED-AT20-001

Medestea Research & Production SpA, Turin

Phase I

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

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

NCT01712425

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

Phase I

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 Sep
9;15(9):e1008011.
Retrovirology 2012,
9(Suppl 2):P328

DermaVir

NCT00712530

Genetic Immunity

Phase I

PLoS One. 2012 7(5):
e35416

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

NCT01881581

Centers for Disease Control and Prevention,
China

Phase I

N/A

HIVAX (lentiviral vector-based therapeutic
vaccine)

NCT01428596

GeneCure Biotechnologies

Phase I

Vaccine. 2020 May
6;S0264-410X(20)30485-0
Vaccine. 2016 Apr
27;34(19):2225-32

HIV-v (peptide-based
vaccine)

NCT01071031

PepTcell Limited

Phase I

Vaccine. 2013 Nov
19;31(48):5680–6

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

NCT02413645

Biomedical Research Institute August Pi i Sunyer
(IDIBAPS)

Phase I

AIDS. 2018 Oct 4.
[Epub ahead of print]

JS7 DNA + MVA62B (DNA + viral vector
vaccines)

NCT01378156

GeoVax, Inc.

Phase I

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

MAG pDNA vaccine +/- IL-12

NCT01266616

NIAID

Phase I

N/A

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

NCT01859325

NIAID/Profectus Biosciences, Inc.

Phase I

J. Virology May 20,
2020
CROI 2019, Poster abstract 392, Webcast
Sci Transl Med. 2017
Dec 6;9(419). pii: eaan8848

MVA.HIVconsv

NCT01024842

University of Oxford/Medical Research Council

Phase I

N/A

PENNVAX-B (Gag, Pol,
Env) + electroporation

NCT01082692

Inovio Pharmaceuticals

Phase I

Retrovirology 2012, 9(Suppl 2):P276

PENNVAX-B +/-
IL-12 or IL-15

NCT00775424

University of Pennsylvania

Phase I

N/A

Recombinant
adenovirus type 5 vaccine

NCT02762045

Centers for Disease Control and Prevention,
China

Phase I

N/A

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

NCT00107549

NIAID

Phase I

AIDS. 2011 Nov 28;
25(18): 2227–2234

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 (TLR-9) 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 (TLR-3 agonist)

NCT02071095

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

Phase I/II

Front Immunol. 2019
Apr 9;10:725.

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

NCT03060447

Gilead Sciences

Phase Ib

CROI 2020, Abstract 40, Webcast

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

NCT02858401

Gilead Sciences

Phase Ib

Clinical Infectious
Diseases, ciaa1534
IAS 2019, Abstract WEAA0304 (slides)

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

DIORR: Dolutegravir impact on residual replication

NCT02500446

University of Melbourne

Phase IV

The Lancet HIV,
Online First, 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

EClinicalMedicine 18
(2020) 100241

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

NCT01033760

Inserm-ANRS

Phase III

PLoS One. 2013; 8(5):
e64219.

PLoS One. 2013; 8(3):
e59767
IAS
2013, Abstract WEAB0101

IAS Cure Symposium 2013, Presentation

maraviroc

NCT00808002

Germans Trias i Pujol Hospital

Phase III

AIDS. 2014 Jan 28;28(3):325–34

raltegravir +
maraviroc

NCT00935480

Centre Hospitalier Intercommunal de Toulon La
Seyne sur Mer

Phase III

N/A

raltegravir

NCT00554398

Germans Trias i Pujol Hospital

Phase III

Antivir Ther.
2012;17(2):355–64

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

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