Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
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|ClinicalTrials.gov Identifier: NCT00924898|
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute HIV Infection HIV Infections||Drug: efavirenz, emtricitabine, and tenofovir||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||December 2013|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|