HIV Prevention Trials Network
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Nonprofit organization | |
Industry | HIV Prevention Research |
Headquarters | Durham, North Carolina, United States |
Key people |
Myron Cohen, MD, HPTN co-Principal Investigator Wafaa El-Sadr MD, MPH, MPA, HPTN co-Principal Investigator |
Website | www.hptn.org |
The HIV Prevention Trials Network (HPTN) 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 research agenda is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions. 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 (HIVNET). HPTN’s Leadership and Operations Center (LOC), is based at FHI 360, Durham, NC. Its Laboratory Center (LC) is at Johns Hopkins University, Baltimore, MD and its Statistical and Data Management Center (SDMC) is housed within the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
HPTN receives its funding from three NIH institutes: the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health and the National Institute on Drug Abuse.
Snapshot
- 53 trials ongoing or completed
- More than 161,000 study participants enrolled
- 300+ publications
- 86 sites in 19 countries
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 (EC). The EC includes investigators from the Clinical Trials Units (CTUs), the Leadership and Operations Center (LOC), the Statistical and Data Management Center (SDMC), the Laboratory Center (LC), Community representatives, National Institutes of Health (NIH) representatives, and other individuals with expertise in HPTN scientific research areas.
The EC, under the direction of HPTN Principal Investigators (PIs) Myron Cohen, MD, and Wafaa El-Sadr, MD, MPH, MPA, in conjunction with the NIH, sets the research priorities of the HPTN and directs its scientific agenda.
Network groups and committees
The HPTN is a global network of investigators from Clinical Trials Units (CTUs), Leadership and Operations Center (LOC) which includes recognized experts in HIV prevention, leadership partners from the network Laboratory Center (LC) and Statistical and Data Management Center (SDMC) and various working groups (WGs) and committees charged with the scientific management and operational support of the network.
The EC Chair recommends, and the full EC approves, chair(s) 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 five key standing Network oversight and operations committees: Science Review Committee (SRC), Study Monitoring Committee (SMC), Manuscript Review Committee (MRC), Performance Evaluation Committee (PEC), and Policies and Procedures Group (PPG).
Studies
HPTN studies strive to prevent HIV infection through the use of antiretroviral drugs, interventions for substance abuse, 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.
Pre-exposure prophylaxis (PrEP) strategies
Antiviral Drugs
- HPTN 084 is a Phase III clinical trial comparing the efficacy and safety of injectable cabotegravir (CAB) to Truvada® for prevention of HIV aquisition in women in Botswana, Kenya, Malawi, South Africa, Swaziland, Uganda and Zimbabwe.
- HPTN 083 is a Phase IIb/III clinical trial comparing the efficacy and safety of injectable cabotegravir (CAB) to Truvada® for prevention of HIV aquisition in cisgender MSM and transgender women who have sex with men in Argentina, Brazil, Peru, South Africa, Thailand, the United States and Vietnam.
- HPTN 082 is a sub-Saharan-based research study designed to assess the number of and characteristics of young women who accept versus decline pre-exposure prophylaxis (PrEP) at enrollment. The study is also comparing adherence to PrEP between women who are randomized to receive standard adherence support and those receiving enhanced adherence support.
- HPTN 077 is a study being done to learn more about the safety and acceptability of a drug called cabotegravir when taken orally and injected by HIV uninfected men and women.
- HPTN 076 is a Phase II clinical research study that was designed to find out if a new form of the drug rilpivirine is safe and acceptable for use as HIV pre-exposure prophylaxis (PrEP).
- HPTN 069/ACTG 5305 was astudy to learn more about the safety and acceptability of oral maraviroc in at risk HIV uninfected men who have sex with men (MSM) and in at-risk HIV uninfected women.
- HPTN 052 was a Phase III, two-arm, randomized, controlled, multi-center trial to determine whether antiretroviral therapy (ART) can prevent the sexual transmission of HIV-1 in HIV-1 serodiscordant couples. The study found a relationship between HIV prevention and AIDS treatment. Science named this study as the 2011 "Breakthrough of the Year".[1]
Monoclonal Antibodies
The HPTN and the HIV Vaccine Trials Network (HVTN) are studying monoclonal antibodies (mAbs) 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.
- HVTN 127/HPTN 087 is a Phase I clinical trial evaluating the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults in Switzerland and the United States.
- HVTN 704/HPTN 085, also known as Antibody Mediated Prevention (AMP), is a Phase IIb clinical trial evaluating the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody (bnAb), in reducing acquisition of HIV-1 infection among men and transgender persons (TG) who have sex with men in Brazil, Peru, Switzerland and the United States.
- HVTN 703/HPTN 081, also known as Antibody Mediated Prevention (AMP), is a Phase IIb clinical trial evaluating the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody (bnAb), in reducing the acquisition of HIV-1 infection among sexually active women in sub-Saharan Africa.
Integrated strategies
- HPTN 078 is a US-based research study designed to develop and determine the effectiveness of a combined HIV prevention strategy that includes a method to identify, recruit, and link men who have sex with men (MSM) to HIV care and an intervention to help HIV-infected MSM achieve and maintain viral suppression (low level of HIV in the body).
- HPTN 075 aimed to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for HIV prevention studies in sub-Saharan Africa.
- HPTN 074 aims to determine the feasibility of a future trial that would assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) would reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.
- HPTN 071 Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) is a research study that examined the impact of a package of HIV prevention interventions on community-level HIV incidence. The prevention interventions included universal voluntary HIV counseling and testing provided at household level, linkage of HIV infected individuals to care and early initiation of antiretroviral therapy (ART) for all those testing HIV-positive. The study was conducted in 21 communities in the Western Cape of South Africa, and in Zambia.
Scholars program
HPTN offers two scholarship programs for early-career investigators funded through a supplement from the National Institute of Allergy and Infectious Diseases and the National Institute on Drug Abuse. The HPTN Scholars Program now includes two components: a domestic (U.S.) program and an international program. Both programs seek to increase opportunities for scientists from groups under-represented in HIV prevention research. In the domestic program, successful applicants will be Investigators who have received their terminal degree (MD, PhD, etc.). For the international version, current MD, PhD, and MBChB students may apply, along with individuals having already graduated with their terminal degree. In both programs, applicants should desire to work with a mentor scientist in the Network to complete a research project based upon an existing HPTN research study.
The HPTN Scholars Program seeks to provide scholar recipients with the knowledge, skills and connections to further their careers as independent investigators in the HIV prevention research field.
Scholars will:
- Develop a research project using data from a completed or ongoing HPTN HIV prevention study and complete their scholarship project within the program cycle
- Present the findings of their project at the HPTN Annual Meeting and submit a manuscript at the end of the scholarship cycle
- Become knowledgeable of the process of doing research in NIH-funded HIV networks, and have the opportunity to build their research networks within the context of the HPTN
Scholars are provided funding to cover a portion of their time (typically ~ 10-30%) and expenses including travel and research materials/supplies. Successful applicants will be funded for 18 months, subject to certain restrictions.
Community program
Community participation and engagement are critical in the conduct of scientific research. There is mutual benefit to communities and researchers when both parties work together throughout the scientific research process. In the HPTN, community participation occurs throughout the network, community and site levels through various mechanisms that include representation on the Ethics Working Group, the Science Review Committee and protocol teams.
References
- ↑ "HIV Study Named 2011 Breakthrough of the Year by Science". niaid.nih.gov. 2011. Retrieved 24 December 2011.