HIV Infections
Conditions
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
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).
Detailed description
In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \< 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.
Interventions
DRUGAmprenavir
Sponsors
Glaxo Wellcome
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed