NCT00734344

Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

Pilot Study of Raltegravir/Tenofovir/Emtricitabine Versus Efavirenz/Tenofovir/Emtricitabine for Adults With Acute HIV-1 Infection: Exploring the Role of Integrase Inhibition in Early HIV Pathogenesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute HIV Infection

Interventions

Type	Name	Description
DRUG	Raltegravir	Raltegravir 400 mg. BID
DRUG	Efavirenz	600 mg once daily
DRUG	Emtricitibine	200mg once daily
DRUG	Tenofovir disoproxil once daily	300mg once daily
DRUG	Tenofovir disoproxil twice daily	300mg twice daily

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2008-08-14
• Last updated: 2016-05-30
• Results posted: 2016-05-30

Locations

1 site across 1 country: United States