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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by ViiV Healthcare
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00791700
First received: November 12, 2008
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Drug: Maraviroc
Phase 4

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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • To determine the safety and tolerability of maraviroc in HIV-infected children and adolescents. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe the efficacy of multiple dose administration of maraviroc in treatment experienced children infected with CCR5 tropic HIV-1; [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Describe tropism changes over time. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: February 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc

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.

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.
Other Name: Selzentry

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791700

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90027
Pfizer Investigational Site Recruiting
Orange, California, United States, 92868
United States, Delaware
Pfizer Investigational Site Terminated
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Pfizer Investigational Site Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Pfizer Investigational Site Recruiting
Jacksonville, Florida, United States, 32209
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33136
Pfizer Investigational Site Recruiting
St Petersburg, Florida, United States, 33701
Pfizer Investigational Site Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Pfizer Investigational Site Terminated
Atlanta, Georgia, United States, 30322
United States, Mississippi
Pfizer Investigational Site Terminated
Jackson, Mississippi, United States, 39216
Pfizer Investigational Site Terminated
Jackson, Mississippi, United States, 39213
United States, Ohio
Pfizer Investigational Site Terminated
Cincinnati, Ohio, United States, 45206
United States, Texas
Pfizer Investigational Site Terminated
Dallas, Texas, United States, 75235
Pfizer Investigational Site Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Pfizer Investigational Site Recruiting
Richmond, Virginia, United States, 23298
Brazil
Pfizer Investigational Site Recruiting
Porto Alegre, RS, Brazil, 90020-090
Pfizer Investigational Site Recruiting
São Paulo, SP, Brazil, 01246-900
Italy
Pfizer Investigational Site Recruiting
Padova, Italy, 35128
Pfizer Investigational Site Recruiting
Roma, Italy, 00165
Pfizer Investigational Site Terminated
Torino, Italy, 10126
Mexico
Pfizer Investigational Site Terminated
Mexico, DF, Mexico, 06720
Portugal
Pfizer Investigational Site Recruiting
Faro, Portugal, 8000-386
Pfizer Investigational Site Recruiting
Lisboa, Portugal, 1649-035
Pfizer Investigational Site Recruiting
Lisboa, Portugal, 1169-045
Pfizer Investigational Site Active, not recruiting
Porto, Portugal, 4202-451
Puerto Rico
Pfizer Investigational Site Recruiting
Rio Piedras, Puerto Rico, 00928
South Africa
Pfizer Investigational Site Recruiting
Benoni, Gauteng, South Africa, 1501
Pfizer Investigational Site Recruiting
Benoni, Gauteng, South Africa, 1500
Pfizer Investigational Site Recruiting
Ga-Rankuwa, Gauteng, South Africa, 0208
Pfizer Investigational Site Recruiting
Dundee, Kwazulu-Natal, South Africa, 3000
Pfizer Investigational Site Recruiting
Bloemfontein, South Africa, 9301
Pfizer Investigational Site Terminated
Pretoria, South Africa, 0083
Spain
Pfizer Investigational Site Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Pfizer Investigational Site Recruiting
Madrid, Spain, 28041
Thailand
Pfizer Investigational Site Recruiting
Bangkok noi, Bangkok, Thailand, 10700
Pfizer Investigational Site Terminated
Muang, Chiang Mai, Thailand, 50200
Pfizer Investigational Site Terminated
Muang, Khon Kaen, Thailand, 40002
Pfizer Investigational Site Recruiting
Bangkok, Thailand, 10330
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00791700     History of Changes
Other Study ID Numbers: A4001031
Study First Received: November 12, 2008
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014