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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002193

Run by

Glaxo Wellcome

People needed

210

Last updated by the study team

2005-06-24

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Diagnostic Treatment Ctr — Fort Lauderdale, Florida, United States
• Saint Jude Children's Hosp / Dept of Infect Diseases — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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