Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
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:
- 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.
- 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).
- To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.
|Acute HIV Infection HIV Infections||Drug: efavirenz, emtricitabine, and tenofovir||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Number of Participants Without Virologic Failure at Week 24 [ Time Frame: HIV RNA level prior to or at week 24 following enrollment ]Number of participants with a HIV RNA level <200 copies/mL at week 24
- Number of Participants Without Virologic Failure at Week 48 [ Time Frame: HIV RNA level at week 48 following enrollment ]HIV RNA level <50 copies/mL at week 48
- Number of Participants With HIV RNA Suppression at Week 96 [ Time Frame: HIV RNA level at 96 weeks following enrollment ]Number of participants wtih HIV RNA level <50 copies/mL at week 96
- Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications [ Time Frame: At enrollment ]Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization
- Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment [ Time Frame: At enrollment ]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 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 ]Number of days from ART initiation to HIV RNA suppression <50 copies/mL
|Study Start Date:||January 2005|
|Study Completion Date:||December 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Acute HIV Treatment Group
Single arm, open label study in which all participants received the same study treatment with efavirenz, emtricitabine, and tenofovir DF
Drug: efavirenz, emtricitabine, and tenofovir
Once daily ART with emtricitabine, tenofovir DF and efavirenz
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924898
|United States, North Carolina|
|The University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Durham, North Carolina, United States, 27707|
|Principal Investigator:||Cynthia Gay, MD, MPH||University of North Carolina, Chapel Hill|