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
  Purpose

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)


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

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 ]
  • UK-427,857 pharmacokinetics [ Time Frame: Days 1-11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: July 2003
Study Completion Date: December 2003
Arms Assigned Interventions
Experimental: 1 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
Experimental: 2 Drug: Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
Other Name: Celsentri, Selzentry
Experimental: 3 Drug: Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
Other Name: Celsentri, Selzentry
Experimental: 4 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
Placebo Comparator: 5 Other: Placebo
Matching placebo oral tablet on Days 1-10 (fed and fasted)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00634959

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-2050
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Germany
Pfizer Investigational Site
Frankfurt, Germany, 60596
Pfizer Investigational Site
Hamburg, Germany, 20099
Pfizer Investigational Site
Koeln, Germany, 50931
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: NCT00634959     History of Changes
Other Study ID Numbers: A4001015
Study First Received: March 5, 2008
Last Updated: November 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV Infections
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 August 21, 2014