Acute HIV and HIV Cure Studies

SEARCH 010 (RV254) is an observational study in Bangkok, Thailand, screening `30,000 prospective participants each year to identify antibody negative but HIV RNA (viral load) positive individuals with Acute HIV Infection (AHI). Participants are enrolled at the Anonymous Clinic of the Thai Red Cross AIDS Research Centre. The objective of SEARCH 010 is to describe clinical, immunological, and virological characteristics of persons with acute HIV infection, to understand the biological and cllinical impact of very early antiretroviral treatment, and to identify and follow volunteers who may be candidates for future HIV intervention or treatment protocols due to diagnosis and treatment during acute infection. Neurologic studies in SEARCH 010/RV254 include optional lumbar puncture, brain imaging approaches with MRI, neuropsychological and mood testing, and inventories of sociodemographic parameters.

SEARCH 013 (RV304) provides control data for comparison with SEARCH 010 and other studies. Involving a variety of optional procedures, including lumbar puncture, lymph node and gut biopsy, and MRI/MRS/DTI, SEARCH 013 compares HIV-negative and chronic HIV-positive participants to the AHI cohort of SEARCH 010. In particular, the study strives to characterize the immunological landscape of locations where viral reservoirs are established, including the gut mucosa and central nervous system.

SEARCH 022 was a treatment interruption study that tracked participants during analytical treatment interruption (ATI) after ART started in acute infection. As in all interruption studies at SEARCH, participants will be monitored frequently and put back on ART if rebound is detected.

SEARCH 025 (RV412) is an ongoing surveillance study for participants who have completed an analytic treatment interruption study at SEARCH. Most participants have resumed ART after viral load rebound and are followed closely during and after the phase of viral re-suppression. Participants not on ART at study start will be monitored closely and put back on ART if rebound is detected.

RV 398 is a protocol designed to study the co-administration of a vaccine and ART during Acute HIV Infection (AHI). The vaccine in question is VRC01, a monoclonal antibody capable of neutralizing HIV-1 by recognizing the location of the viral protein gp120, which binds to the host T-cell's CD4 receptor. This Phase I study examines the safety and impact of VRC01 (given in conjunction with conventional ART) on viral dynamics during AHI.

RV 397 is a treatment interruption study, recruiting from SEARCH 010, that tests the efficacy of VRC01 administration during analytic treatment interruption. The study enrolled HIV-infected participants who initiated antiretroviral therapy (ART) within the first few weeks of infection and who have successfully suppressed viral load with ART for at least two years. As in all interruption studies, participants were monitored frequently and put back on ART if rebound is detected.

SEARCH 018 (RV408) examines the impact on the nervous system of administering and adjunctive anti-inflammatory therapy with ART during AHI. The study investigates the effects of the anti-inflammatory agent, telmisartan, in reducing systemic immune activation and trafficking of activated and HIV-infected cells into the CNS.

SEARCH 026 (RV424) is a treatment interruption study designed to investigate the nervous system effects of co-administering a histone deacetylase (HDAC) inhibitor combined with other medications and ART, followed by ATI. The study recruited participants who had been on ART for at least 42 weeks from SEARCH 010. As in all interruption studies, participants were monitored frequently and put back on ART if rebound was detected.

Armed Forces Research Institute of Medical Sciences (AFRIMS) (Thailand and US)

Chulalongkorn University (Bangkok, Thailand)

Henry M. Jackson Foundation (HJF) (Bethesda, Maryland)

Southeast Asia Research Collaboration with Hawaii (SEARCH) (Bangkok, Thailand)

Thai Red Cross AIDS Research Centre (TRCARC) (Bangkok, Thailand)

University of California, San Francisco

University of Hawaii, Manoa

University of Missouri, St. Louis

University of North Carolina, Chapel Hill

U.S. Military HIV Research Program (MHRP) (Bethesda, Maryland)

Walter Reed Army Institute of Research (WRAIR) (Rockville, Maryland)

R01MH106466 (PIs Spudich/Trautmann) Critical Role of Cytotoxic T Cells in HIV Neuropathogenesis

R01NS084911 (PIs Spudich/Ananworanich) Therapeutic Interventions during Acute Infection to Address the CNS Reservoir for HIV

R01MH104141 (PI Ndhlovu) Monocytes and HIV CNS Reservoirs in Super Acute HIV Infection

W81XWH-11-2-0174; IAA number NIAID Y1-AI502602 Global Acute HIV Infection CNS Studies

R01MH095613-01 (PIs Spudich/Valcour) Long-term CNS Consequences of Treatment during Acute HIV Infection