HPTN Studies

Our studies strive to prevent HIV acquisition and transmission through the use of antiretroviral drugs, interventions for substance use, behavioral risk reduction, and structural interventions.

HPTN research studies are developed by protocol teams that include CTU investigators and recognized experts in HIV prevention. As study protocols are developed, they undergo a rigorous intra- and extra-Network review process that ensures compliance with current ethical guidelines and regulatory procedures. Each Study Protocol is available once version 1.0 is approved and distributed to the performance sites.

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HVTN 143/HPTN 109 (39015)

A phase 1- clinical trial to evaluate the safety, tolerability, pharmacokinetics and tolerability of combinations of monoclonal antibodies VRC01.23LS, PGT121.414.LS, and PGDM1400LS administered via intravenous infusion in adults without HIV

Withdrawn

Antibody Mediated Prevention

A5416/HVTN 806/HPTN 108 (39006)

A Phase I, Randomized, Placebo-Controlled Study of the Safety, Antiviral & Immunomodulatory Activity of Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in Combination in ART-treated Adults in sub-Saharan Africa Living with HIV during a Monitored Analytical Treatment Interruption

Participants Off Study and Primary Analysis Completed

Antibody Mediated Prevention

DMID 19-0004/HPTN 107

A Phase II randomized, observer-blind, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection.

Closed to Accrual

STI

HPTN 106 (39002)

A Phase 2 Crossover Study of On Demand PrEP Formulations Comparing Rectal and Oral TFV-Based PrEP Evaluating Extended Safety, Acceptability, and PK/PD

Closed to Accrual

PrEP

HPTN 104 (39007)

A multisite, open-label, randomized crossover study comparing adherence to a single daily dual prevention pill (DPP) versus FTC/TDF and Combined Oral Contraception separate pill dosing (2PR), given for pre-exposure prophylaxis and pregnancy prevention in women

Pending

MPT

HVTN 140/HPTN 101 (154188)

A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV-uninfected adult participants