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

ViiV Healthcare

Status and phase: Unknown; Phase 2

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Maraviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791700

2008-006873-33 (EudraCT Number)

A4001031

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

103 participants in 1 patient group

Maraviroc

Experimental group

Description:

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.

Treatment:

Drug: Maraviroc