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

NCT00022763 Phase 2 COMPLETED Results posted

This study will evaluate T-20 in children.

Details

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	COMPLETED
Enrolment	52
Start date	2001-08

Conditions

• HIV Infections

Interventions

• Enfuvirtide

Primary outcomes

• Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) — Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
  The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.

Countries

United States