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

Condition(s) targeted: Human Immunodeficiency Virus (HIV)

Intervention: Maraviroc (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: ViiV Healthcare

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To determine the safety and tolerability of maraviroc in HIV-infected children and adolescents.

To determine the pharmacokinetic profile(s) and dosing schedule(s) for maraviroc in treatment experienced HIV-infected children and adolescents on different background therapies;

Secondary outcome:

Describe the efficacy of multiple dose administration of maraviroc in treatment experienced children infected with CCR5 tropic HIV-1;

Describe tropism changes over time.

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Genova 16132, Italy; Not yet recruiting

Pfizer Investigational Site, Padova 35128, Italy; Recruiting

Pfizer Investigational Site, Roma 00165, Italy; Recruiting

Pfizer Investigational Site, Torino 10126, Italy; Terminated

Pfizer Investigational Site, Faro 8000-386, Portugal; Recruiting

Pfizer Investigational Site, Lisboa 1169-045, Portugal; Recruiting

Pfizer Investigational Site, Lisboa 1649-035, Portugal; Recruiting

Pfizer Investigational Site, Porto 4202-451, Portugal; Recruiting

Pfizer Investigational Site, Rio Piedras 00928, Puerto Rico; Recruiting

Pfizer Investigational Site, Bloemfontein 9301, South Africa; Recruiting

Pfizer Investigational Site, Pretoria 0083, South Africa; Terminated

Pfizer Investigational Site, Madrid 28041, Spain; Recruiting

Pfizer Investigational Site, Mwanza, Tanzania; Not yet recruiting

Pfizer Investigational Site, Bangkok 10330, Thailand; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85016, United States; Recruiting

Pfizer Investigational Site, Bangkok noi, Bangkok 10700, Thailand; Recruiting

Pfizer Investigational Site, Esplugues de Llobregat, Barcelona 08950, Spain; Recruiting

Pfizer Investigational Site, Los Angeles, California 90027, United States; Recruiting

Pfizer Investigational Site, Orange, California 92868, United States; Recruiting

Pfizer Investigational Site, Muang, Chiang Mai 50200, Thailand; Terminated

Pfizer Investigational Site, Mexico, DF 06720, Mexico; Terminated

Pfizer Investigational Site, Wilmington, Delaware 19803, United States; Recruiting

Pfizer Investigational Site, Washington, District of Columbia 20010, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32209, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33136, United States; Recruiting

Pfizer Investigational Site, St Petersburg, Florida 33701, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33612, United States; Recruiting

Pfizer Investigational Site, Benoni, Gauteng 1501, South Africa; Active, not recruiting

Pfizer Investigational Site, Benoni, Gauteng 1500, South Africa; Active, not recruiting

Pfizer Investigational Site, Ga-Rankuwa, Gauteng 0208, South Africa; Recruiting

Pfizer Investigational Site, Johannesburg, Gauteng, South Africa; Not yet recruiting

Pfizer Investigational Site, Atlanta, Georgia 30322, United States; Terminated

Pfizer Investigational Site, Soweto, Johannesburg, South Africa; Not yet recruiting

Pfizer Investigational Site, Muang, Khon Kaen 40002, Thailand; Terminated

Pfizer Investigational Site, Dundee, Kwazulu-Natal 3000, South Africa; Active, not recruiting

Pfizer Investigational Site, Jackson, Mississippi 39213, United States; Terminated

Pfizer Investigational Site, Jackson, Mississippi 39216, United States; Terminated

Pfizer Investigational Site, Cincinnati, Ohio 45206, United States; Terminated

Pfizer Investigational Site, Porto Alegre, RS 90020-090, Brazil; Not yet recruiting

Pfizer Investigational Site, São Paulo, SP 01246-900, Brazil; Recruiting

Pfizer Investigational Site, Dallas, Texas 75235, United States; Terminated

Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting

Pfizer Investigational Site, Richmond, Virginia 23298, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: February 2009
Last updated: January 17, 2013