Conditions: Acute HIV Infection HIV Infections
Keywords: Acute HIV HIV Acute Infections Acute Infection
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 92
Healthy volunteers: no

Brief summary:
This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:

1. To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.
2. To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions).
3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.

Detailed description:
Hypothesis: Once daily ART with fixed dose combination FTC/TDF/EFV will reduce viral replication to \<200 copies RNA/ml plasma in blood and other body compartments in patients with acute HIV infection, reducing infectivity. The treatment regimen will be well tolerated during treatment follow-up. A coordinated program of counseling and support will facilitate adherence and promote successful therapy. Prevalence of transmitted drug resistant HIV-1 will be assessed.

Study Design: Dual-center, prospective, single-arm pilot study of FTC/TDF/EFV in patients with acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Patients will be followed intensively for 96 weeks.

Arms:
arm 1: Single arm, open label study in which all participants received the same study treatment with efavirenz, emtricitabine, and tenofovir DF

Interventions: intervention 1: efavirenz, emtricitabine, and tenofovir
Intervention descriptions: intervention 1: Once daily ART with emtricitabine, tenofovir DF and efavirenz

Protocol document: