T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents

This study will evaluate T-20 in children.

Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.

Inclusion Criteria

Patients may be eligible for this study if they:

• Are 3 through 16 years of age and have the consent of parent or guardian.
• Have a viral load of at least 5000 copies/ml.
• Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
• Have been on stable therapy for at least 4 weeks.