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

HIV Infections Clinical Trial

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

Clinical Trial Summary

This study will evaluate T-20 in children.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00022763
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 2
Start date August 2001
View Details
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