Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus (hiv)
Treatment maraviroc
Phase phase 2
Sponsor ViiV Healthcare
Collaborator Pfizer
Start date April 2009
End date April 2015
Trial size 125 participants
Trial identifier NCT00791700, 2008-006873-33, A4001031

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects will be stratified by age and formulation into one of the following cohorts: Cohort 1: ≥2-<6 years of age, maraviroc liquid formulation; Cohort 2: ≥6-<12 years of age, maraviroc tablet formulation; Cohort 3: ≥6-<12 years of age, maraviroc liquid formulation and Cohort 4: ≥12-<18 years of age, maraviroc tablet formulation.
maraviroc Selzentry
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.

Primary Outcomes

Measure
To determine the safety and tolerability of maraviroc in HIV-infected children and adolescents.
time frame: 48 weeks
To determine the pharmacokinetic profile(s) and dosing schedule(s) for maraviroc in treatment experienced HIV-infected children and adolescents on different background therapies;
time frame: 48 weeks

Secondary Outcomes

Measure
Describe the efficacy of multiple dose administration of maraviroc in treatment experienced children infected with CCR5 tropic HIV-1;
time frame: 48 weeks
Describe tropism changes over time.
time frame: 48 weeks

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

Inclusion Criteria: - Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL Exclusion Criteria: - X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay - Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs) - Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase; - Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST < 2.5 X ULN; No symptoms other than jaundice or icterus. - Other laboratory values ≥Grade 3, must be reviewed by Pfizer.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by ViiV Healthcare.