HIV Infections Clinical Trial
Official title:
CID 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis
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 HAART with FTC/TDF (FDC, Truvada) + EFV administered as a single dose
pill called Atripla will reduce viral replication to <400 copies RNA/ml plasma in blood and
other body compartments in patients with acute HIV infection, reducing infectivity, and
permitting generation of HIV-specific immune responses. The treatment regimen will be well
tolerated and any lipid profile changes will be modest 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: Multi-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 the first year with continued
follow-up for an additional year pending developments on treatment cessation approaches for
patients with suppressed virus and effective immune responses.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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