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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Once daily ART with emtricitabine, tenofovir DF and efavirenz
The University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Number of Participants Without Virologic Failure at Week 24
Number of participants with a HIV RNA level \<200 copies/mL at week 24
Time frame: HIV RNA level prior to or at week 24 following enrollment
Number of Participants Without Virologic Failure at Week 48
HIV RNA level \<50 copies/mL at week 48
Time frame: HIV RNA level at week 48 following enrollment
Number of Participants With HIV RNA Suppression at Week 96
Number of participants wtih HIV RNA level \<50 copies/mL at week 96
Time frame: HIV RNA level at 96 weeks following enrollment
Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization
Time frame: At enrollment
Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization
Time frame: At enrollment
Time to HIV RNA Suppression <50 Copies/mL
Number of days from ART initiation to HIV RNA suppression \<50 copies/mL
Time frame: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96
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