Active, not recruiting

Study Description:

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.

Viiv Study ID:

A4001031


Has Results Document Available
Clinicaltrials.gov Identifier:

NCT00791700


Has Results Available Below
EudraCT Number:

2008-006873-33


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

maraviroc

Collaborators

Pfizer, Inc.


Date

April 2009 to April 2015

Type

Interventional

Phase

2


Gender

Both

Age

2 Years - 18 Years

Accepts Healthy Volunteers

No


Study Documents

This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    Not available

  • Central Contact Phone:

    1-800-718-1021

  • Central Contact Email:

    [email protected]

Brazil, São Paulo 01416-000No longer recruiting
Brazil, SP, São Paulo 01246-900No longer recruiting
Italy, Roma 00165Terminated
Italy, Torino 10126Terminated
Italy, ITALY, Padova 35128No longer recruiting
Italy, ITALY, Padova 35128No longer recruiting
Mexico, DF, Mexico 06720Terminated
Portugal, Faro 8000-386No longer recruiting
Portugal, Lisboa 1169-045No longer recruiting
Portugal, Lisboa 1649-035No longer recruiting
Portugal, Porto 4202-451Terminated
Puerto Rico, PR, San Juan 00935No longer recruiting
South Africa, Pretoria 0083Terminated
South Africa, Free State, Bloemfontein 9301No longer recruiting
South Africa, Gauteng, Benoni 1501No longer recruiting
South Africa, Gauteng, Ga-Rankuwa 0208No longer recruiting
South Africa, KWAZULU-NATAL, Dundee 3000No longer recruiting
Spain, MADRID 28041No longer recruiting
Spain, SPAIN, Esplugues de Llobregat, Barcelona 08950No longer recruiting
Thailand, BANGKOK, Bangkok 10700No longer recruiting
Thailand, BANGKOK, Bangkok 10330No longer recruiting
Thailand, CHIANG MAI, Muang 50200Terminated
Thailand, KHON KAEN, Muang 40002Terminated
United States, CA, Los Angeles 90027No longer recruiting
United States, CA, Orange 92868No longer recruiting
United States, DC, Washington 20010No longer recruiting
United States, DE, Wilmington 19803No longer recruiting
United States, FL, Jacksonville 32209Terminated
United States, FL, Jacksonville 32209Terminated
United States, FL, Miami 33136No longer recruiting
United States, FL, Tampa 33612No longer recruiting
United States, GA, Atlanta 30322Terminated
United States, GA, Atlanta 30308Terminated
United States, MS, Jackson 39216Terminated
United States, MS, Jackson 39213Terminated
United States, MS, Jackson 39216Terminated
United States, OH, Cincinnati 45206Terminated
United States, TX, Dallas 75235Terminated
United States, TX, Houston 77030No longer recruiting
United States, TX, Houston 77030No longer recruiting
United States, VA, Richmond 23298No longer recruiting
United States, VA, Richmond 23298No longer recruiting

Study Design

  • Primary Purpose: Treatment
  • Allocation: Not Available
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Pharmacokinetic (PK) Parameters for participants with data in Stage 1 enrolled in Stage 2 – Week 48
    Timeframe: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

  • PK Parameters for Stage 1 participants Enrolled in Stage 2 – Week 2 Results for Stage 2 doses - AUCtau (Area under the curve at steady state)
    Timeframe: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

  • PK Parameters for Stage 1 participants Enrolled in Stage 2 – Week 2 Results for Stage 2 doses - Tmax (Time at maximum concentration)
    Timeframe: Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)

  • Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (All Causality)
    Timeframe: 48 weeks

  • Treatment discontinuation secondary to Serious Adverse Event (SAE) related to study drug
    Timeframe: Week 48

Secondary Outcomes:

  • Percentage of participants with HIV‑1 RNA <400 copies/mL through Week 48 (MSDF)
    Timeframe: Week 24 and Week 48 post-treatment.

  • Percentage of participants with HIV‑1 RNA <48 copies/mL through Week 48 (MSDF)
    Timeframe: Week 24 and Week 48 post-treatment

  • Percentage of Participants with HIV-1 RNA Levels <400 copies/mL at Weeks 24 and 48 using Missing, Discontinuation = Failure (MD=F)Approach
    Timeframe: Week 24 and Week 48 post-treatment

  • Percentage of Participants with HIV-1 RNA Levels < 48 copies/mL at Weeks 24 and 48 using MD=F Approach
    Timeframe: Week 24 and Week 48 post-treatment

  • Percentage of participants with HIV-1 RNA <400 copies/mL and <48 copies/mL using the time to loss of virologic response algorithm (TLOVR) at Week 48
    Timeframe: Week 48

  • Percentage of Participants with >= 1.0 log10 reduction in HIV-1RNA concentration from baseline to Week 24 and Week 48
    Timeframe: Week 24 and Week 48 post-treatment

  • Summary of Change from Baseline in HIV-1 RNA (Original) by Visit
    Timeframe: Week 24 and Week 48 post-treatment

  • Summary of Change from Baseline in HIV-1 RNA (Log10 copies/mL) by Visit
    Timeframe: Week 24 and Week 48 post-treatment

  • Change from Baseline in cluster of differentiation 4 (CD4+) cell count at weeks 24 and 48
    Timeframe: Week 24 and Week 48 post-treatment

  • Change from Baseline in CD4+ Percent (%) at weeks 24 and 48
    Timeframe: Week 24 and Week 48 post-treatment

  • Protocol Defined Virologic Failure
    Timeframe: Week 48

  • Shift Table of Viral Tropism between Screening and Confirmed PDVF Prior to Week 48
    Timeframe: Screening and Week 48

  • Summary of the Emergence of reverse transcriptase inhibitor (RTI) and protease inhibitor (PI) resistance associated mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF: Total and by Cohort Prior to Week 48
    Timeframe: 48 weeks

  • Optimized Background Treatment (OBT) Susceptibility Scores (Net/Overall) by Outcome
    Timeframe: 48 weeks

Arms:
  • 1

Interventions:

  • Drug: Maraviroc

Keyword:

  • Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 103

Clinical Publications:

  • Giaquinto C, Mawela MP, Chokephaibulkit K, et al. Pharmacokinetics, safety and efficacy of maraviroc in treatment experienced pediatric patients infected with CCR5-tropic HIV-1. Pediatr Infect Dis J. 2018;37(5):459-465.