A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

Phase 3

Completed

• Conditions: HIV Infection

• Registration Number: NCT00053638
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-02-04
• Study First Submitted QC: 2003-02-04
• Study First Posted: 2003-02-05
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-01
• Last Update Posted: 2010-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Viral load response at 48 weeks	48 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics	48 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Green Bay, Wisconsin, United States