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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.
Verified March 2013 by ViiV Healthcare
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00791700
First received: November 12, 2008
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

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

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

  Show 43 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: March 12, 2013
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 March 14, 2013