Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002416
• Lead Sponsor: Triangle Pharmaceuticals

Brief Summary

The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.

Detailed Description

Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1). Arm 1: Replace lamivudine with FTC while continuing on current background regimen. Arm 2: Continue on current lamivudine-containing regimen. Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy. Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen. Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen. Stratum 3: 50-400 copies/ml; PI in treatment regimen. Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen. Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.

Study Timeline

• Study First Submitted: 1999-11-02
• Status Verified: 2000-03
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Dr Robert Wallace; 🇺🇸 St. Petersburg, Florida, United States

North Shore Univ Hosp; 🇺🇸 Great Neck, New York, United States