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
A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children
2 other identifiers
interventional
210
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (2)
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, 33301, United States
Saint Jude Children's Hosp / Dept of Infect Diseases
Memphis, Tennessee, 38105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06