Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Acute HIV Infection
• Communicable Diseases
• HIV Infections
• Infection

• NCT number: NCT00924898
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Completion date: December 2013