Antiretroviral Therapy Research
(TasP and PrEP)
Overview
Treatment as Prevention (TasP) - Antiretroviral therapy (ART) became available in the late 1980’s and has been shown to dramatically reduce morbidity and mortality of HIV infection. Highly active antiretroviral therapy (HAART) has resulted in reductions of community-level viral loads. Research strategies were developed to examine the possibility that ART adherence among HIV-positive people may not only delay disease progression at the individual level, but may also reduce the viruses’ ability to be transmit to HIV-negative sexual partners. The HPTN’s seminal serodiscordant couples study HPTN 052 demonstrated that HIV transmission was reduced by 96% in serodiscordant couples when ART was initiated early. The study findings were subsequently used to revise World Health Organization (WHO) and U.S. treatment guidelines.
Because the use of ART as treatment as prevention also requires expanded testing, care engagement and adherence, the HPTN’s research agenda has included a variety of studies that include different approaches that communities may be able to implement. Links to those studies are included in the table shown below.
Pre-Exposure Prophylaxis (PrEP) - Pre-exposure prophylaxis (PrEP) is a prevention strategy that requires an HIV negative person to take ART on a set schedule prior to being exposed to HIV. In 2010, the iPrEx study showed that daily use of Truvada® reduced the risk of HIV infection by 44 percent in HIV-negative men who have sex with men. In 2011, two other studies also showed that Truvada® was effective in reducing HIV infection among heterosexual men and women. Based on all of these studies, in mid-2012, the Food and Drug Adminstration (FDA) approved the use of Truvada® for HIV prevention.
Since PrEP has the advantage of not requiring the participation of a sexual partner, it may be complementary to other prevention modalities such as condom use. PrEP represents an important new concept for empowering women and men to protect themselves from HIV. Links to current and concluded HPTN PrEP studies are provided below.
HPTN ART Studies
|
Treatment as prevention for injection drug users: A pilot study for a network-based randomized HIV prevention trial |
(In Development) | |
|
Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence among Black Men who have Sex with Men (BMSM) in Three U.S. Cities |
(Pending) | |
|
Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART): A cluster-randomized trial of the impact of a combination prevention package on population-level HIV incidence in Zambia and South Africa |
(Pending) | |
|
International Test and Linkage to Care and Treatment |
(Withdrawn) | |
|
Phase II Randomized, Double-Blind, Study of Safety and Tolerability of Maraviroc, Maraviroc + Emtricitabine, Maraviroc + Tenofovir or Tenofovir + Emtricitabine for PreExposure Prophylaxis to Prevent HIV Transmission in At-Risk Men Who Have Sex with Men |
(Enrolling) | |
|
Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate in Healthy Volunteers |
(Re-Opened) | |
|
TLC-Plus: A Study to Evaluate the Feasibility of an Enhanced Test, Link to Care, Plus Treat Approach for HIV Prevention in the United States |
(Enrolling) | |
|
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 |
(Closed to Accrual) |
| HPTN 043 | 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 |
(Closed to Accrual) |
