UCSF HIV Clinical Trials Unit

Investigator: Diane Havlir, MD
Sponsor: NIH National Institute of Allergy and Infectious Disease

Location(s): United States


     The UCSF HIV Clinical Trials Unit (CTU) will study treatment of HIV and its complications and prevention of HIV transmission in resource rich and poor settings through the ACTG and IMPAACT networks. This newly formed CTU creates a dynamic research agenda spanning pediatric to adult disease and features accomplished and innovative researchers, a cross-cutting research agenda, HIV infected clinic populations totaling 14,000, experienced clinical trials staff, strong mentoring programs and community participation. Dr. Havlir, chief of the HIV/AIDS Division at San Francisco General Hospital will direct the CTU and lead the adult UCSF Clinical Research Site (CRS) affiliated with ACTG; Dr. Wara will lead the pediatric, adolescent and pregnant women CRS, working through IMPAACT; Dr. Kamya will lead the adult CRS of Makerere University/Infectious Diseases Institute in Uganda, as a site for the ACTG. Our CTU contributions will occur in the NIH high priority research areas of optimization of clinical management and co-morbidities; translational research/drug development; prevention of mother to child transmission and vaccines. We will closely collaborate with the VTN/HPTN-affiliated San Francisco Department of Public Health prevention CTU in promoting a coordinated approach to prevention and treatment research in our community. Our goals: Aim 1: Design and conduct research to define simple, safe and lifelong antiretroviral treatment (ART) strategies for children and adults; new drugs and novel agents including vaccines for HIV and its complications; innovative approaches to treat HIV co-morbidities such as TB, malaria, HPV, hepatitis B and C, and studies of viral dynamics, reservoirs, and genomics to understand pharmacokinetics and treatment responses in HIV infected participants enrolled from CRS sites at UCSF and Makerere University. Aim 2. Integrate the HIV treatment and prevention research agenda at the scientific, operational and community level by catalyzing scientific exchange, operations, and community outreach between prevention and treatment groups, testing novel strategies to prevent vertical and horizontal transmission. Aim 3. Foster the development of the next generation of patient based researchers by mentoring junior investigators, leveraging support of existing funding training programs such as Fogarty and CFAR. Aim 4. Conduct research with community-based input and outreach through vibrant community advisory boards and CTU support of community education and dissemination of research findings. The relevance of this research is that the studies will define new standards for the treatment of HIV disease and its complications and will improve ways to prevent transmission of HIV from mother to child.