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
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, SW10 9NH
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00643643     History of Changes
Other Study ID Numbers: A4001007
Study First Received: March 19, 2008
Last Updated: November 9, 2010
Health Authority: The Netherlands: EMEA

Keywords provided by ViiV Healthcare:
HIV
Treatment Naïve

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014