Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
This is a single-site, investigator-initiated, open-label, randomized/controlled clinical
trial to compare the viral load response in plasma (and, in a subset of subjects, in
gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection
treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with
tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than
a commitment to life-long HAART, as has been the experimental approach in a variety of
clinical protocols in the United States and Europe. Subjects will complete a 12 week course
of therapy, and those who meet treatment-response and safety criteria will then undergo a
similarly intensive period of virology and immunology monitoring to compare the timing and
dynamics of any observed virologic rebound following the treatment intervention.
Phase:
N/A
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Efavirenz Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Raltegravir Potassium Tenofovir