A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

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

Summary

The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Indinavir; Lamivudine; Nelfinavir; Stavudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are at least 18 years old.

• Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.

• Have a CD4 cell count of at least 50 cells/mm3.

• Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)

• Agree to abstain from sex or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have a history of an AIDS-defining illness or certain other medical conditions.

• Are allergic to any of the study drugs.

• Are unable to take medication by mouth for any reason.

• Have received certain medications.

• Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.

• Are pregnant or breast-feeding.