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

Launched by TRIANGLE PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are at least 18 years old.
• • Are HIV-positive.
• • Have a viral load below 400 copies/ml.
• • Agree to use a barrier method of birth control (such as condoms) during the study.
• • Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.)
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
• • Have had a serious medical event within 30 days prior to study entry.
• • Are taking hydroxyurea.
• • Have Grade 2 or higher peripheral neuropathy.
• • Abuse alcohol or drugs.
• • Are pregnant or breast-feeding.