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Immediate Initiation of Antiretroviral Therapy During Acute HIV Infection (DGVTAF)
The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with very early HIV infection (estimated date of infection within the last 90 days). The primary aim of the study is to evaluate whether initiation of dolutegravir plus emtricitabine/tenofovir during acute/early HIV infection leads to protection of CD4+ T cells and other immune cells in the peripheral blood and lymphoid tissue from infection.
Details
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 74 |
| Start date | 2015-12 |
| Completion | 2028-05 |
Conditions
- HIV
Interventions
- Dolutegravir
- Emtricitabine/Tenofovir
Primary outcomes
- Safety and tolerability of immediate Dolutegravir plus Emtricitabine/Tenofovir administered to acutely infected HIV patients. — 6 months
The number of grade 2 or higher severity adverse events (AEs) or drug-related laboratory abnormalities that exceed a frequency of 5% over a 6 month study period.
Countries
United States