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 (antibody inhibitor of HIV binding to CD4 receptors)

NCT03743376

United BioPharma

Phase II

December 2020

vedolizumab
(anti-α₄β₇ integrin antibody)

NCT03577782

Hospitales
Universitarios Virgen del Rocío

Phase II

May 2020

vedolizumab

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

NCT03254277
(closed
to enrollment)

Rockefeller University

Phase I

August 2020

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

NCT04250636
(not yet open for enrollment)

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

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

NCT03205917
(closed
to enrollment)

International AIDS
Vaccine Initiative

Phase I

December 2020

SAR441236 (tri-specific broadly
neutralizing antibody)

NCT03705169
(closed
to enrollment)

NIAID

Phase I

June 2021

VRC01 + 10-1074

NCT03831945

NIAID

Phase I

March 2024

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 2022

ANTI-PROLIFERATIVE

mycophenolate mofetil
(MMF)

NCT03262441
(closed
to enrollment)

Fred Hutchinson
Cancer Research Center

Phase I

August 2021
CROI 2020, Abstract 340

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

maraviroc, dolutegravir, dendritic cell vaccine, auranofin, nicotinamide

NCT02961829
(closed to enrollment)

Federal University of São Paulo

Not
listed

March 2020
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

January 2021

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

NCT04364035

Aelix Therapeutics

Phase IIa

December 2022

ROADMAP: romidepsin
+ 3BNC117

NCT02850016
(closed to enrollment)

Rockefeller
University

Phase IIa

July 2020
CROI 2020, Abstract 38, Webcast

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

NCT03837756

University
of Aarhus

Phase IIa

February 2021

eCLEAR: romidepsin + 3BNC117

NCT03041012

Aarhus University
Hospital

Phase II

April 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 2021

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
(not yet open for enrollment)

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

September 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
(suspended due to COVID-19)

Wistar Institute

Phase I

May 2022

VRC07-523LS + vorinostat

NCT03803605
(closed
to enrollment)

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

interleukin-2 (IL2)

NCT03308786

Case Western Reserve
University

Phase II

December 2021

DUAL-AFFINITY RE-TARGETING
(DART) MOLECULES

MGD014

NCT03570918

MacroGenics

Phase I

March 2020

GENE THERAPIES

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

CD4 CAR + SB-728mR modified
T cells

NCT03617198
(closed to enrollment)

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

April 2022

shRNA-modified CD34+ cells

NCT03517631

Shanghai Public
Health Clinical Center

Phase I

December 2020

Anti-gp120 CAR-T cells (autologous T cells gene-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

June 2031

GONADOTROPIN-RELEASING HORMONE
(GnRH) AGONISTS

triptorelin acetate depot

NCT03536234

Immune System
Regulation AB

Phase II

December 2020

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

NCT03063788

Bayside Health

Phase I

July 2019

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.

cemiplimab (anti-PD-1 antibody)

NCT03787095
(closed
to enrollment)

NIAID

Phase I/II

August 2020
ACTG announcement

budigalimab
(anti-PD-1 antibody)

NCT04223804

AbbVie

Phase Ib

March 2022

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

NCT02408861
(suspended
due to COVID-19)

National Cancer
Institute (NCI)

Phase I

December 2020
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
2020
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

valproic acid +
pyrimethamine

NCT03525730

Erasmus Medical
Center

Phase I/II

April 2020

arsenic trioxide

NCT03980665

Guangzhou 8th
People’s Hospital

Phase I

December 2021

Kansui (traditional Chinese
medicine containing ingenols)

NCT02531295

UCSF

Phase I

December 2020

PROTEASOME INHIBITORS

ixazomib

NCT02946047
(closed
to enrollment)

Mayo Clinic

Phase I

September 2020

STEM CELL TRANSPLANTATION

HIVECT: HIV eradication through cord-blood transplantation

NCT02923076

Puerta de
Hierro University Hospital

N/A

December 2018

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

NCT02140944

International
Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)

N/A

March 2023
ASH 2018, Abstract 2184

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

NCT04083170
(not yet
open for enrollment)

Fred Hutchinson
Cancer Research Center

Phase II

December 2022

HLA-mismatched
unrelated donor bone marrow transplantation

NCT02793544
(closed
to enrollment)

Center for
International Blood and Marrow Transplant Research

Phase II

April 2020

STIMULANTS

EMRLHD: Effect of methamphetamine on residual latent HIV disease study

NCT03825536

University of
California, San Francisco

Phase IV

August 2023

THERAPEUTIC VACCINES

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

NCT03560258
(closed to enrollment)

NIAID

Phase I/II

September 2020

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

NCT03606213

Steven Deeks, UCSF

Phase I/II

December 2020

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

February 2022

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
(not yet open for 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

September 2020

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

NCT03844386
(closed to enrollment)

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

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

NCT02431975
(closed
to enrollment)

Columbia University

Phase IV

July 2020
EClinicalMedicine 18
(2020) 100241

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

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

NCT02987530
(closed
to enrollment)

Inserm/ANRS

Phase III

December 2019

EIT: Early infant HIV
treatment in Botswana

NCT02369406

Harvard School of
Public Health

Phase II/III

July 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

May 2021

Trial

Trial
Registry Identifier(s)

Manufacturer/
Sponsor(s)

Phase

Estimated
End Date/Interim Results

2000HIV: 2000 HIV Human
Functional Genomics Partnership Program

NCT03994835
(not yet open for enrollment)

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

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

June 2020

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

September 2020

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

NCT02674867
(closed
to enrollment)

Inserm-ANRS

N/A

June 2019

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
(not yet
open for enrollment)

Inserm-ANRS

N/A

November 2020

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

January 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

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

NCT03416790
(closed
to enrollment)

IMPAACT

N/A

April 2020

Impact of ART adherence on HIV persistence and inflammation

NCT02797093
(closed
to enrollment)

University of
Colorado, Denver

N/A

October 2020

Long-term effects of
ART in acute HIV infection

ChiCTR1800015006
(not yet open for enrollment)

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

August 2019

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

Post analytic treatment interruption study

NCT02761200

South East Asia
Research Collaboration with Hawaii

N/A

July 2020

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

December 2020
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
(not yet open for enrollment)

Centre Hospitalier
Universitaire de Nīmes

N/A

December 2020

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

NCT03622177

Inserm-ANRS

N/A

September 2023

SCOPE-ATI: SCOPE analytic treatment interruption protocol

NCT04359186
(not yet open for enrollment)

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

July 2020

Thinking and memory
problems in people with HIV

NCT01875588

National Institute of
Neurological Disorders and Stroke (NINDS)

N/A

February 2027

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
(closed
to enrollment)

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

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.

PGT121

NCT02960581

International AIDS
Vaccine Initiative

Phase I

CROI 2019, Abstract 145, Webcast

vedolizumab

NCT02788175

NIAID

Phase I

AIDS 2018, WESS0102

VRC01

NCT02411539

NIAID

Phase I

N/A

VRC01

NCT02471326

NIAID

Phase I

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

VRC01

NCT02463227

NIAID

Phase I

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

VRC01

NCT01950325

NIAID

Phase I

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

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

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

CROI 2020, Abstract 506
HIV DART 2018

BIT225

ACTRN
12612000696897

Biotron Limited

Phase I

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

COMBINATIONS

chemotherapy
+ maraviroc in people with non-Hodgkin lymphoma

NCT02486510

Fundacion para la
Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Phase 0

Terminated due to
futility criteria

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

AIDS 2016, Abstract TUAX0101LB

AGS-004 +
vorinostat

NCT02707900

NIAID

Phase I

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

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

Front
Immunol. 2020 May 6;11:823.
CROI 2019, Abstract 438
CROI 2017, Abstract 119LB, Webcast

CYTOKINES

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

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

IMMUNE CHECKPOINT INHIBITORS

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

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

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

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

N/A

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

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

NCT03198325

Ospedale San Raffaele

N/A

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

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

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

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.

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

NCT00968630

Fred Hutchinson
Cancer Research Center

Phase II

N/A

THERAPEUTIC VACCINES

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

NCT00672191

Argos Therapeutics

Phase IIb

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

AGS-004

NCT01069809

Argos Therapeutics

Phase IIb

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

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

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

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

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

peginterferon alfa-2b

NCT01935089

University of
Pennsylvania/Wistar Institute

Phase II

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