A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

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

Summary

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Lamivudine; Lamivudine, zidovudine drug combination; Nelfinavir; Stavudine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 18 years old.

• Are HIV-positive.

• Have a CD4 count greater than 50 cells/mm3.

• Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.

• Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)

• Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.

• Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.

• Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.

• Are enrolled in another study.

• Cannot take medications by mouth or absorb drugs.

• Have hepatitis.

• Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.

• Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).

• Are taking certain medications.

• Are pregnant or breast-feeding.