Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

NCT00634959

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-2050, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Asymptomatic HIV-1 infected male and female patients

- Weight between 50 and 100kg and within the permitted range for their height

- Patients with virus that targets CCR5 receptor

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


- Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL


- Patients whose HIV infection has been diagnosed less than 3 months prior to screening,
or for who there is evidence of recent seroconversion


- Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis


- Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to
the study screening visit

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Official Title  ICMJE An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)
Brief Summary To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: Maraviroc (UK-427,857)
    150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
    Other Name: Celsentri, Selzentry
  • Drug: Maraviroc (UK-427,857)
    100 mg oral tablet once daily while fasted on Days 1-10
    Other Name: Celsentri, Selzentry
  • Drug: Maraviroc (UK-427,857)
    300 mg oral tablet once daily while fasted on Days 1-10
    Other Name: Celsentri, Selzentry
  • Drug: Maraviroc (UK-427,857)
    150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
    Other Name: Celsentri, Selzentry
  • Other: Placebo
    Matching placebo oral tablet on Days 1-10 (fed and fasted)
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Maraviroc (UK-427,857)
  • Experimental: 2
    Intervention: Drug: Maraviroc (UK-427,857)
  • Experimental: 3
    Intervention: Drug: Maraviroc (UK-427,857)
  • Experimental: 4
    Intervention: Drug: Maraviroc (UK-427,857)
  • Placebo Comparator: 5
    Intervention: Other: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2008)
37
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2008)
36
Actual Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Asymptomatic HIV-1 infected male and female patients
  • Weight between 50 and 100kg and within the permitted range for their height
  • Patients with virus that targets CCR5 receptor

Exclusion Criteria:

  • Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
  • Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
  • Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
  • Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00634959
Other Study ID Numbers  ICMJE A4001015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date November 2010

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