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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: November 12, 2008
Last updated: September 18, 2015
Last verified: September 2015
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.
Human Immunodeficiency Virus (HIV)
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||April 2015 (Final data collection date for primary outcome measure)
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 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
|Ages Eligible for Study:
||2 Years to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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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
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 12, 2008
||September 18, 2015
||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:
ClinicalTrials.gov processed this record on November 27, 2015
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases