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

NCT00791700

Last updated date
Study Location
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Immunodeficiency Virus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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  1. Los Angeles, California
  2. Orange, California
  3. Wilmington, Delaware
  4. Washington, District of Columbia
  5. Jacksonville, Florida
  6. Miami, Florida
  7. Tampa, Florida
  8. Atlanta, Georgia
  9. Atlanta, Georgia
  10. Jackson, Mississippi
  11. Jackson, Mississippi
  12. Jackson, Mississippi
  13. Cincinnati, Ohio
  14. Dallas, Texas
  15. Houston, Texas
  16. Houston, Texas
  17. Richmond, Virginia
  18. Richmond, Virginia
  19. São Paulo, SP
  20. São Paulo,
  21. Padova,
  22. Padova,
  23. Roma,
  24. Torino,
  25. Mexico, DF
  26. Faro,
  27. Lisboa,
  28. Lisboa,
  29. Porto,
  30. San Juan,
  31. Bloemfontein, FREE State
  32. Benoni, Gauteng
  33. Ga-Rankuwa, Gauteng
  34. Dundee, Kwazulu-natal
  35. Pretoria,
  36. Esplugues De Llobregat, Barcelona,
  37. Madrid,
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  4. Bakersfield, California
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  6. Fountain Valley, California
  7. Long Beach, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Oakland, California
  12. Orange, California
  13. Palm Desert, California
  14. Palo Alto, California
  15. Sacramento, California
  16. San Francisco, California
  17. San Francisco, California
  18. Stanford, California
  19. Victorville, California
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  21. Denver, Colorado
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  24. New Haven, Connecticut
  25. New Haven, Connecticut
  26. Norwalk, Connecticut
  27. Washington, District of Columbia
  28. Washington, District of Columbia
  29. Washington, District of Columbia
  30. Washington, District of Columbia
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  32. Boynton Beach, Florida
  33. Daytona Beach, Florida
  34. Fort Myers, Florida
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  38. Miami, Florida
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  45. Tampa, Florida
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  61. Chicago, Illinois
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  63. Olympia Fields, Illinois
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  66. Iowa City, Iowa
  67. Lexington, Kentucky
  68. Lexington, Kentucky
  69. Lexington, Kentucky
  70. New Orleans, Louisiana
  71. New Orleans, Louisiana
  72. Silver Spring, Maryland
  73. Brighton, Massachusetts
  74. Springfield, Massachusetts
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  79. Lansing, Michigan
  80. Lansing, Michigan
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  89. Newark, New Jersey
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  97. New York, New York
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  114. Harrisburg, Pennsylvania
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  123. Columbia, South Carolina
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  126. Dallas, Texas
  127. Dallas, Texas
  128. Dallas, Texas
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  8. Miami, Florida
  9. Safety Harbor, Florida
  10. Tampa, Florida
  11. Atlanta, Georgia
  12. Jonesboro, Georgia
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  14. Chicago, Illinois
  15. Wichita, Kansas
  16. Jackson, Mississippi
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  18. New York, New York
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  24. Portland, Oregon
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  28. Dallas, Texas
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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: Maraviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 28, 2016)
103
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
125
Estimated Study Completion Date  ICMJE June 30, 2023
Actual Primary Completion Date April 14, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Italy,   Mexico,   Portugal,   Puerto Rico,   South Africa,   Spain,   Thailand,   United States
Removed Location Countries France,   Tanzania
 
Administrative Information
NCT Number  ICMJE NCT00791700
Other Study ID Numbers  ICMJE A4001031
2008-006873-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party ViiV Healthcare
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP