Conditions: Acute HIV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Raltegravir plus Truvada arm 2: Efavirenz plus Truvada

Interventions: intervention 1: Raltegravir intervention 2: Efavirenz intervention 3: Emtricitibine intervention 4: Tenofovir disoproxil once daily intervention 5: Tenofovir disoproxil twice daily
Intervention descriptions: intervention 1: Raltegravir 400 mg. BID intervention 2: 600 mg once daily intervention 3: 200mg once daily intervention 4: 300mg once daily intervention 5: 300mg twice daily

Protocol document: