CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 103 enrolled
Drug / intervention
Maravirocdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00791700
NCT00791700Phase 2Unknown
CompareCT.gov

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

ViiV Healthcare·interventional·Posted Nov 14, 2008·Updated Apr 28, 2020

In Brief

A Phase 2 clinical trial evaluating Maraviroc for Human Immunodeficiency Virus. Targeting 103 participants across 41 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesBrazil, Italy, Mexico, Portugal, Puerto Rico, South Africa, Spain, Thailand, United States
CollaboratorsPfizer

Timeline

Phase 2UnknownOverdue
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 14, 2008
Enrollment StartApr 22, 2009
Primary CompletionApr 14, 2015
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 17.6 years ago

Interventions

Maravirocdrug

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.