Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

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

Summary

The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).

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

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Amprenavir; HIV Protease Inhibitors; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria

Your child may be eligible for this study if he/she:

• Is 6 months - 18 years of age.

• Is HIV-positive.

• Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.

• Is able to take medications by mouth.

• Has consent of parent or legal guardian if under 18.

• Has a negative pregnancy test within 7 days of study entry.

• Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

• Has a serious illness, including any life-threatening infection or other chronic serious medical condition.

• Has an opportunistic (AIDS-related) infection or a serious bacterial infection.

• Is allergic to NRTIs.

• Is breast-feeding.

• Is unlikely to complete the study.

• Has received certain medications.

• Has received radiation therapy within the past 4 months, or will need to receive it during the study.