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

NCT00924898 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2017-05-16

Study results available
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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.

Conditions

  • Acute HIV Infection
  • HIV Infections

Interventions

DRUG

efavirenz, emtricitabine, and tenofovir

Once daily ART with emtricitabine, tenofovir DF and efavirenz

Sponsors & Collaborators

Principal Investigators

  • Cynthia Gay, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00924898 on ClinicalTrials.gov