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

Roche

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: Enfuvirtide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00022763

NV16056

295E

T20-310

Details and patient eligibility

About

This study will evaluate T-20 in children.

Full 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.

Enrollment

52 patients

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.