NCT00791700

An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children

AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC, SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2 - <18 YEARS OF AGE

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Maraviroc	Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.

Timeline

• Start date: 2009-04-22
• Primary completion: 2015-04-14
• Completion: 2023-06-30
• First posted: 2008-11-14
• Last updated: 2020-04-28
• Results posted: 2016-02-25

Locations

41 sites across 9 countries: United States, Brazil, Italy, Mexico, Portugal, Puerto Rico, South Africa, Spain, Thailand

Regulatory

• FDA-regulated drug study