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):
ViiV Healthcare Identifier:
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.

Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Drug: Maraviroc
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel 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: April 2009
Estimated Study Completion Date: July 2019
Primary Completion Date: April 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


Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00791700

  Hide Study Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Delaware
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
Rainbow Center at University of Florida Health
Jacksonville, Florida, United States, 32209
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
All Children's Hospital
St Petersburg, Florida, United States, 33701
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Grady Infectious Disease Center
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Mississippi
Pediatric Infectious Disease Clinic
Jackson, Mississippi, United States, 39213
Batson Specialty Clinic
Jackson, Mississippi, United States, 39216
University of Mississippi
Jackson, Mississippi, United States, 39216
United States, Ohio
Cincinnati Center for Clinical Research
Cincinnati, Ohio, United States, 45206
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at Houston Pediatrics Infectious Diseases
Houston, Texas, United States, 77030
UT Physician
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
VCU Health System General Clinical Research Center
Richmond, Virginia, United States, 23298
Instituto de Infectologia Emilio Ribas
São Paulo, SP, Brazil, 01246-900
Clinica Pediatrica ,Azienda Ospedaliera di Padova
Padova, Italy, 35128
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive
Torino, Italy, 10126
Hospital Infantil de Mexico Federico Gomez
Mexico, DF, Mexico, 06720
Hospital Distrital de Faro, EPE
Faro, Portugal, 8000-386
Hospital D. Estefânia -Serviço de Infecciologia
Lisboa, Portugal, 1169-045
Centro Hospitalar de Lisboa Norte, EPE
Lisboa, Portugal, 1649-035
Hospital S. João
Porto, Portugal, 4202-451
Puerto Rico
Hospital San Juan Research Unit
San Juan, Puerto Rico, 00935
South Africa
Iatros International
Bloemfontein, Free state, South Africa, 9301
Benmed Clinic
Benoni, Gauteng, South Africa, 1501
Dr George Mukhari Hospital
Ga-Rankuwa, Gauteng, South Africa, 0208
Dr. J Fourie Medical Centre
Dundee, Kwazulu-Natal, South Africa, 3000
Embassy Drive Medical Center
Pretoria, South Africa, 0083
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok noi, Bangkok, Thailand, 10700
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand, 50200
Department of Pediatric, Faculty of Medicine, Khon Kaen University
Muang, Khon Kaen, Thailand, 40002
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
Bangkok, Thailand, 10330
Sponsors and Collaborators
ViiV Healthcare
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare Identifier: NCT00791700     History of Changes
Other Study ID Numbers: A4001031  2008-006873-33 
Study First Received: November 12, 2008
Last Updated: September 18, 2015
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
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on February 10, 2016