The HIV/AIDS Clinical Trials Networks conduct NIH-funded clinical research worldwide in collaboration with one another, NIAID, other partner NIH Institutes and Centers, industry, and non-governmental research organizations. Each network addresses a key area of research emphasis to accelerate progress against the HIV pandemic, including HIV prevention; HIV vaccines; HIV/AIDS adult therapeutics; and HIV/AIDS maternal, adolescent, and pediatric therapeutics.
Funded by the Division of AIDS (DAIDS) of the U.S. National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), the HIV/AIDS Clinical Trials Networks include:
The AIDS Clinical Trials Group (ACTG) was initially established in 1987 to broaden the scope of the AIDS research effort of the National Institute of Allergy and Infectious Diseases (NIAID). The ACTG established and supports the largest Network of expert clinical and translational investigators and therapeutic clinical trials units in the world, including sites in resource-limited countries. These investigators and units serve as the major resource for HIV/AIDS research, treatment, care, and training/education in their communities.
The work accomplished by the ACTG has had a profound impact on the well-being of persons infected with HIV-1. Clinical trials and laboratory studies conducted by the ACTG have made major contributions to optimizing antiretroviral therapy (ART), managing drug resistance, preventing and treating co-infections, evaluating acute and long-term toxicities, and demonstrating the importance of pharmacogenomics in predicting drug toxicities. Results of these studies have helped establish the paradigm for the management of HIV disease and form the basis of current treatment guidelines. This progress in the treatment of HIV-1-infected individuals has resulted in dramatic reductions in AIDS mortality in the U.S. and other countries of the developed world.
The mission of the ACTG is to cure HIV infection and reduce the burden of disease due to HIV infection and its complications, including tuberculosis and viral hepatitis.
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 HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.
The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally.
Over the past decade, the HVTN has aimed to improve the process of designing, implementing, and analyzing vaccine trials. Several major achievements include streamlining protocol development while maintaining input from diverse stakeholders, establishing a laboratory program with standardized assays and systems allowing for reliable assessments across trials, setting statistical standards for the field, and actively engaging with site communities. These achievements have allowed the HVTN to conduct over 50 clinical trials and make numerous scientific contributions to the field.
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives and other partners organized for the purpose of evaluating interventions to treat and prevent HIV infection and its consequences in infants, children, adolescents and pregnant/postpartum women through the conduct of high quality clinical trials.
The IMPAACT Network's research agenda includes evaluation of: new and existing anti-HIV drugs and formulations; novel approaches for addressing tuberculosis in HIV-infected or at-risk populations; biomedical/behavioral interventions to prevent mother-to-child HIV transmission; immunogenicity, safety and efficacy of high priority vaccines; potential for HIV cure through therapeutic interventions; and methods to prevent and manage complications and comorbidities of HIV infection and its treatment.
The MTN brings together international investigators and community and industry partners whose work is focused on the rigorous evaluation of promising microbicides – products applied inside the vagina or rectum to prevent the sexual transmission of HIV – and of dual-purpose products for preventing both HIV and unintended pregnancy.
MTN studies are designed specifically to support the potential licensure and regulatory approval of these products for particularly vulnerable populations: adolescent girls and young women; pregnant and breastfeeding women, gay men and other men who have sex with men and transgender women. More than 25 clinical research sites on four continents have partnered with the MTN in the conduct of its clinical trials. Collectively, more than 11,000 research participants have taken part in MTN studies.
HANC is based at Fred Hutchinson Cancer Research Center in Seattle, WA and has provided leadership and logistical support for cross-network coordination efforts since 2004.