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Pharmacokinetics, Pharmacodynamics, And Safety 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:
NCT00643643
First received: March 19, 2008
Last updated: November 9, 2010
Last verified: November 2010
History of Changes

March 19, 2008
November 9, 2010
October 2002
June 2003   (final data collection date for primary outcome measure)
  • Change from baseline in viral load [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of UK-427,857 [ Time Frame: Days 1 and 10 ] [ Designated as safety issue: No ]
  • Receptor saturation [ Time Frame: Days 1, 5, 10, 11, 13, 15, 19, 40 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00643643 on ClinicalTrials.gov Archive Site
  • 12-lead electrocardiography [ Time Frame: Days 1-11 and Day 40 ] [ Designated as safety issue: Yes ]
  • Time course of viral load from baseline to follow-up [ Time Frame: Days 1-15 and Days 19, 22, 25, 40 ] [ Designated as safety issue: No ]
  • Time to rebound of viral load [ Time Frame: Days 1-15 and Days 19, 22, 25, 40 ] [ Designated as safety issue: No ]
  • The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
  • The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10) [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
  • The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90) [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Days 1-40 ] [ Designated as safety issue: Yes ]
  • Laboratory safety testing [ Time Frame: Days 1, 3, 7, 11, 15, 40 ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Days 1, 11, 40 ] [ Designated as safety issue: Yes ]
  • Supine and standing blood pressure and pulse rate [ Time Frame: Days 1-11 and Day 40 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
A Randomised, Double Blind, Placebo-Controlled, Multicentre Study Of UK-427,857 25mg O.D. , 50mg B.I.D., 100mg B.I.D And 300mg B.I.D. In Asymptomatic HIV Infected Patients To Investigate Pharmacodynamics, Pharmacokinetics, Safety And Toleration.
To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV Infections
  • Drug: Maraviroc (UK-427,857)
    25 mg oral tablet once daily for 10 days
    Other Name: Celsentri, Selzentry
  • Drug: Maraviroc (UK-427,857)
    50 mg oral tablet twice daily for 10 days
    Other Name: Celsentri, Selzentry
  • Drug: Maraviroc (UK-427,857)
    100 mg oral tablet twice daily for 10 days
    Other Name: Celsentri, Selzentry
  • Drug: Maraviroc (UK-427,857)
    300 mg oral tablet twice daily for 10 days
    Other Name: Celsentri, Selzentry
  • Other: Placebo
    Matching placebo oral tablet twice daily for 10 days
    Other Name: Celsentri, Selzentry
  • Experimental: A
    Intervention: Drug: Maraviroc (UK-427,857)
  • Experimental: B
    Intervention: Drug: Maraviroc (UK-427,857)
  • Experimental: C
    Intervention: Drug: Maraviroc (UK-427,857)
  • Experimental: D
    Intervention: Drug: Maraviroc (UK-427,857)
  • Placebo Comparator: E
    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
41
June 2003
June 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion criteria:

  • Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV
  • Weight between 50 and 90kg and within the permitted range for their height

Exclusion Criteria:

Exclusion criteria:

  • Subjects with a CD4 count less than 250cells/mm3 or HIV viral load of less than 5000 copies/mL
  • Subjects with acquired immune deficiency syndrome (AIDS) or a previous AIDS diagnosis
  • Subjects whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
  • Subjects who have taken anti-retroviral drugs in the eight weeks prior to the study screening visit
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   United Kingdom
 
NCT00643643
A4001007
No
Not Provided
Not Provided
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