CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
efavirenz, emtricitabine, and tenofovirdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00924898
NCT00924898Phase 4Completed

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

University of North Carolina, Chapel Hill·interventional·Posted Jun 19, 2009·Updated May 16, 2017

In Brief

A Phase 4 clinical trial evaluating efavirenz, emtricitabine, and tenofovir for Acute HIV Infection and HIV Infections. Completed, enrolled 92 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2009
Enrollment StartJan 1, 2005
Primary CompletionNov 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 17.0 years ago

Interventions

efavirenz, emtricitabine, and tenofovirdrug

Once daily ART with emtricitabine, tenofovir DF and efavirenz