Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

Phase 2 Completed 59 enrolled ViiV Healthcare GlaxoSmithKline · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.

Timeline

Start: 2003-10-23
Primary completion: 2011-07-05
Completion: 2022-03-29

Publications

Background Cotton M, Cassim H, Pavia-Ruz N, Garges HP, Perger T, Ford SL, Wire MB, Givens N, Ross LL, Lou Y, Sievers J, Cheng K. Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-infected children aged 4 weeks to 2 years-48-week study data. Pediatr Infect Dis J. 2014 Jan;33(1):57-62. doi: 10.1097/INF.0b013e3182a1123a.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fosamprenavir	Small molecule	50 mg/ml	Oral
Subject	Ritonavir	Other / unclassified	80 mg/ml	Oral

Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

Summary

Timeline

Publications

Drugs

Indications