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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:
ClinicalTrials.gov Identifier:
NCT00643643
First Posted: March 26, 2008
Last Update Posted: November 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
  Purpose
To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).

Condition Intervention Phase
HIV Infections Drug: Maraviroc (UK-427,857) Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Change from baseline in viral load [ Time Frame: Day 11 ]
  • Pharmacokinetic profile of UK-427,857 [ Time Frame: Days 1 and 10 ]
  • Receptor saturation [ Time Frame: Days 1, 5, 10, 11, 13, 15, 19, 40 ]

Secondary Outcome Measures:
  • 12-lead electrocardiography [ Time Frame: Days 1-11 and Day 40 ]
  • Time course of viral load from baseline to follow-up [ Time Frame: Days 1-15 and Days 19, 22, 25, 40 ]
  • Time to rebound of viral load [ Time Frame: Days 1-15 and Days 19, 22, 25, 40 ]
  • 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 ]
  • The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10) [ Time Frame: Days 1-11 ]
  • The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90) [ Time Frame: Days 1-11 ]
  • Adverse events [ Time Frame: Days 1-40 ]
  • Laboratory safety testing [ Time Frame: Days 1, 3, 7, 11, 15, 40 ]
  • Physical examination [ Time Frame: Days 1, 11, 40 ]
  • Supine and standing blood pressure and pulse rate [ Time Frame: Days 1-11 and Day 40 ]

Enrollment: 41
Study Start Date: October 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Maraviroc (UK-427,857)
25 mg oral tablet once daily for 10 days
Other Name: Celsentri, Selzentry
Experimental: B Drug: Maraviroc (UK-427,857)
50 mg oral tablet twice daily for 10 days
Other Name: Celsentri, Selzentry
Experimental: C Drug: Maraviroc (UK-427,857)
100 mg oral tablet twice daily for 10 days
Other Name: Celsentri, Selzentry
Experimental: D Drug: Maraviroc (UK-427,857)
300 mg oral tablet twice daily for 10 days
Other Name: Celsentri, Selzentry
Placebo Comparator: E Other: Placebo
Matching placebo oral tablet twice daily for 10 days
Other Name: Celsentri, Selzentry

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643643


Locations
Germany
Pfizer Investigational Site
Bonn, Germany, 53105
Pfizer Investigational Site
Koeln, Germany, 50924
Pfizer Investigational Site
Muenchen, Germany, 80336
Netherlands
Pfizer Investigational Site
Utrecht, Netherlands, 3584 CX
United Kingdom
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00643643     History of Changes
Other Study ID Numbers: A4001007
First Submitted: March 19, 2008
First Posted: March 26, 2008
Last Update Posted: November 10, 2010
Last Verified: November 2010

Keywords provided by ViiV Healthcare:
HIV
Treatment Naïve

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents