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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00634959
First received: March 5, 2008
Last updated: November 9, 2010
Last verified: November 2010

March 5, 2008
November 9, 2010
July 2003
Not Provided
  • Change from baseline in viral load [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
  • UK-427,857 pharmacokinetics [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00634959 on ClinicalTrials.gov Archive Site
  • Physical examination [ Time Frame: Days 1, 11, 40 ] [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Time Frame: Days 1-11 and Day 40 ] [ Designated as safety issue: Yes ]
  • Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10) [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
  • Time course of viral load from baseline to follow-up [ Time Frame: Days 1-13 and Days 15, 19, 22, 25, 40 ] [ Designated as safety issue: No ]
  • CCR5 receptor saturation [ Time Frame: Days 1, 5, 10, 11, 13, 15, 19, 40 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Days 1-40 ] [ Designated as safety issue: Yes ]
  • Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90) [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
  • Laboratory safety [ Time Frame: Days 1, 3, 7, 11, 15, 40 ] [ Designated as safety issue: Yes ]
  • Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10) [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
  • Supine/standing blood pressure and pulse rate [ Time Frame: Days 1-11 and Day 40 ] [ Designated as safety issue: Yes ]
  • Time to rebound of viral load [ Time Frame: Days 1-13 and Days 15, 19, 22, 25, 40 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
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)

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)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2003
Not Provided

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom
 
NCT00634959
A4001015
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
November 2010

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