HIV Prevention Trials Network


The HIV Prevention Trials Network is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN is committed to the highest ethical standards for its clinical trials and recognizes the importance of community engagement in all phases of the research process.
The HPTN was established in 2000, building on the work of the HIV Network for Prevention Trials. HPTN's Leadership and Operations Center is based at FHI 360, Durham, NC. Its Laboratory Center is at Johns Hopkins University, Baltimore, MD and Statistical and Data Management Center is housed within the Statistical Center for HIV/AIDS Research and Prevention at the Fred Hutchinson Cancer Research Center in Seattle, Washington. The HPTN Modeling Centre, part of the SDMC, is a collaboration between the Department of Infectious Diseases Epidemiology at Imperial College London, UK, and SCHARP.
The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN.

Snapshot

  • More than 80 trials ongoing or completed
  • 172,000+ study participants enrolled and evaluated
  • 50 active clinical research sites in 13 countries
  • 880+ publications

    Mission statement

The HPTN is dedicated to the discovery and development of new and innovative research strategies to reduce the acquisition and transmission of HIV.

Leadership

The HPTN leadership group is a subset of the Executive Committee. The EC includes investigators from the Clinical Trials Units, the Leadership and Operations Center, the Statistical and Data Management Center, the Laboratory Center, Community representatives, National Institutes of Health representatives, and other individuals with expertise in HPTN scientific research areas.
The EC, under the direction of HPTN Principal Investigators in conjunction with the NIH, sets the research priorities of the HPTN and directs its scientific agenda.
As of December 2025, Drs. Raphael Landovitz and Sinead Delany-Moretlwe lead the HPTN as co-principal investigators.

Network groups and committees

The HPTN is a global network of investigators from Clinical Trials Units, Leadership and Operations Center which includes recognized experts in HIV prevention, leadership partners from the network Laboratory Center and Statistical and Data Management Center and various working groups and committees charged with the scientific management and operational support of the network.
The EC Chair recommends, and the full EC approves, chair and membership of the HPTN committees. Committee members serve for the duration of the cooperative agreement, and chairs serve three-year terms unless otherwise specified. Terms of committee chairs may be extended with the approval of the EC Chair. In addition to the scientific committees and working groups, there are four key standing Network oversight and operations committees: Science Review Committee, Study Monitoring Committee, Manuscript Review Committee, and Performance Evaluation Committee.

Research agenda

The HPTN research agenda focuses on the following four priority areas:
  1. Identifying novel antiretroviral -based methods and delivery systems for HIV prevention
  2. Developing multi-purpose technologies for HIV prevention as well as for contraception and prevention of other sexually transmitted infections
  3. Evaluating broadly neutralizing antibodies alone or in a combination that prevent HIV acquisition, in collaboration with the HIV Vaccine Trials Network
  4. Designing and conducting population-specific integrated strategy studies that combine biomedical, socio-behavioral, and structural interventions for HIV prevention to maximize their effectiveness

    Pre-exposure prophylaxis (PrEP) strategies

Antiviral Drugs
  • or "REV UP" is a phase II crossover study of on-demand pre-exposure prophylaxis formulations comparing rectal and oral tenofovir-based PrEP evaluating extended safety, acceptability, and pharmacokinetics/pharma co-dynamics.
  • is a phase II, open-label, multicenter, randomized clinical trial to evaluate the feasibility, safety, and acceptability of long-acting subcutaneous lenacapavir vs. daily oral emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis among people who inject drugs.
  • is a phase II, open-label, multicenter, randomized study to evaluate the pharmacokinetics, safety, and acceptability of twice-yearly long-acting subcutaneous lenacapavir for pre-exposure prophylaxis in cisgender women in the U.S.
  • is a clinical trial examining whether injectable cabotegravir for pre-exposure prophylaxis is safe and acceptable for adolescent females.
  • is a phase III study comparing the efficacy and safety of long-acting injectable cabotegravir to Truvada® for prevention of HIV acquisition in women in Botswana, Kenya, Malawi, South Africa, Swaziland, Uganda and Zimbabwe. Data from the HPTN 084 clinical trial indicate that a pre-exposure prophylaxis regimen of long-acting cabotegravir injections once every eight weeks was safe and superior to daily oral tenofovir/emtricitabine for HIV prevention among cisgender women in sub-Saharan Africa.
  • is a clinical trial examining factors influencing adherence to injectable PrEP and retention in an injectable PrEP research study.
  • is a clinical trial examining whether injectable cabotegravir for PrEP is safe and acceptable for adolescent males .
  • is a phase IIb/III study comparing the efficacy and safety of long-acting injectable cabotegravir to Truvada® for prevention of HIV acquisition in cisgender MSM and transgender women who have sex with men in Argentina, Brazil, Peru, South Africa, Thailand, the United States and Vietnam. Data from the HPTN 083 clinical trial showed that a pre-exposure prophylaxis regimen containing long-acting cabotegravir injected once every eight weeks was superior to daily oral tenofovir/emtricitabine for HIV prevention among cisgender men and transgender women who have sex with men.
  • was a phase IV sub-Saharan-based research study designed to assess the number of and characteristics of young women who accept versus decline pre-exposure prophylaxis at enrollment. The study compared adherence to PrEP between women who are randomized to receive standard adherence support and those receiving enhanced adherence support. HPTN 082 data show pre-exposure prophylaxis use was high but waned after three months among the young African women enrolled in the study.
  • was a phase IIa study helping determine whether injectable cabotegravir could be used for PrEP in people at greater risk of acquiring HIV. The study showed that cabotegravir was safe and well-tolerated.
  • was a phase II study designed to find out if a new form of the drug rilpivirine is safe and acceptable for use as HIV pre-exposure prophylaxis. Study findings demonstrated long-acting rilpivirine is safe. Overall there was no difference in the number and type of side effects between the study group receiving long-acting rilpivirine and the study group receiving placebo.
  • was a phase IV demonstration study see if Black men who have sex with men are willing to use Truvada®, a daily pill for pre-exposure prophylaxis. Study findings, based on participant self-report, showed high uptake of PrEP for prevention of HIV infection among BMSM in the U.S. with the use of a novel coordinated counseling and care approach resulting in findings suggestive of a lower rate of HIV infection.
  • was a phase II study designed to learn more about the safety and acceptability of oral maraviroc in at-risk HIV uninfected men who have sex with men and in at-risk HIV uninfected women.
  • HPTN 052 was a phase III landmark study proving viral suppression through antiretroviral therapy can prevent HIV transmission. Based on the study's findings, the World Health Organization recommended antiretroviral treatment be offered to all people living with HIVregardless of CD4 count. Science named this study the 2011 "Breakthrough of the Year".
Data from and helped provide important information for the December 20, 2021 decision by the U.S. Food and Drug Administration to approve ViiV Healthcare's long-acting cabotegravir injections for the prevention of HIV. Sponsored and co-funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, these studies showed that CAB-LA injected once every eight weeks was superior to daily oral tenofovir/emtricitabine for HIV prevention among cisgender men and transgender women who have sex with men and cisgender women. Both studies also demonstrated that CAB-LA was well-tolerated, offering a new and important pre-exposure prophylaxis option for individuals at risk for HIV infection. ViiV Healthcare will market CAB-LA for PrEP under the brand name Apretude.
Monoclonal Antibodies
The HPTN and the HIV Vaccine Trials Network are studying monoclonal antibodies that may protect people from HIV infection. These studies will guide the development of new ways to prevent HIV. They will also guide future vaccine development that could help to end HIV.
  • is 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.
  • is a phase 1, open-label study of the safety, antiviral and immunomodulatory 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.
  • is 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.
  • is an antiretroviral analytical treatment interruption study to assess immunologic and virologic responses in participants who received VRC01 or placebo and acquired HIV during .
  • is an antiretroviral analytical treatment interruption study to assess immunologic and virologic responses in participants who initiated antiretroviral therapy in early HIV infection after having received VRC01 or placebo in .
  • is a phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous infusion or via subcutaneous injections in healthy, HIV-uninfected adult participants.
  • is a phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants
  • is a phase I study evaluating the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB, administered in multiple doses and routes to healthy, HIV-uninfected adults in Switzerland and the United States.
  • Antibody Mediated Prevention, are two phase IIb studies evaluating the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody, in reducing acquisition of HIV-1 infection among cisgender men and transgender persons who have sex with men in Brazil, Peru, Switzerland and the United States, and sexually active cisgender women in sub-Saharan Africa. Findings from the proof-of-concept AMP studies demonstrated VRC01 was effective at preventing the acquisition of HIV strains that were sensitive to the bnAb. This was assessed by a laboratory test that measures a virus' susceptibility to neutralization by an antibody.