HPTN Studies
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.
To view detailed information about studies, including performance sites and enrollment figures, select a protocol number from the tables below. Each Study Protocol is available once version 1.0 is approved and distributed to the performance sites. The CORE Protocol Contact can provide additional information and materials.
Ongoing Studies and Studies in Development
| Protocol Number | Protocol Title | Status |
|---|---|---|
|
10141 |
A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda |
Closed to Accrual |
|
10067 |
Ancillary Study: Prospective Cohort Study of HPTN 039 Seroconverters: The Effect of HSV-2 Suppression on HIV-1 Viral Set Point |
Closed to Accrual |
|
|
A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand |
Enrolling |
|
10142 |
Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding |
Enrolling |
|
10068 |
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples |
Enrolling |
|
10143 |
A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and their Infants |
Enrolling |
|
10144 |
A Phase III randomized controlled trial to evaluate the efficacy of drug treatment in prevention of HIV infection and death among opiate dependent injectors |
Enrolling |
|
10666 |
Feasibility of a community-level, multi-component intervention for Black MSM in preparation for a Phase IIB community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM |
Enrolling |
|
10667 |
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals with Acute and Early HIV-Infection |
Pending |
|
10668 |
Preparing for international prevention trials involving HIV-infected individuals in care settings |
Pending |
|
10705 |
The Women’s HIV SeroIncidence Study (ISIS) |
Enrolling |
|
10841 |
TNT-Plus: A Study to Evaluate the Feasibility of an Enhanced Test-and-Treat Approach for the Prevention of HIV Transmission in the United States |
In Development |
|
10851 |
Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate in Healthy Volunteers |
In Development |
|
10852 |
Behavioral Aspects of PrEP Counseling for Intermittent Exposure |
In Development |
Completed Studies
| Protocol Number | Protocol Title | Status |
|---|---|---|
|
|
A Phase IIB Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates |
Participants Off Study & Primary Analysis Complete |
|
|
EXPLORE: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV among Men who have Sex with Men (MSM) |
Concluded |
|
|
Condom Promotion and Counseling Study |
Concluded |
|
|
Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission |
Participants Off Study & Primary Analysis Complete |
|
|
Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P) |
Concluded |
|
|
HIV Prevention Preparedness Study |
Concluded |
|
10199 |
HIV Incidence and Participant Retention Protocol, Pune, India |
Concluded |
|
10065 |
Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women |
Closed to Follow Up |
|
|
HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Perú |
Concluded |
|
10125 |
A Phase III Randomized Study to Evaluate the Efficacy of a Network-oriented Peer Educator Intervention for the Prevention of HIV Transmission Among Injection Drug Users And Their Network Members |
Participants Off Study & Primary Analysis Complete |
|
10066 |
A Phase III, randomized, double-blind, placebo-controlled trial of acyclovir for the reduction of HIV acquisition among high risk HSV-2 seropositive, HIV-seronegative individuals |
Participants Off Study & Primary Analysis Complete |
|
|
A Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P) |
Concluded |
|
|
Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women |
Concluded |
|
|
Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel |
Concluded |
|
|
HIV Prevention Preparedness Study |
Concluded |
|
|
Characterization of Baseline Mucosal Indices of Injury and Inflammation in Men for Use in Rectal Microbicide Trials |
Concluded |
|
10145 |
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel |
Concluded |
