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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Triangle Pharmaceuticals
• Treatments: Emtricitabine; HIV Protease Inhibitors; Lamivudine; Protease Inhibitors; Reverse Transcriptase Inhibitors; Stavudine; Zidovudine

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.