Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

November 9, 2010 updated by: ViiV Healthcare

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Pfizer Investigational Site
      • Koeln, Germany, 50924
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site
      • London, United Kingdom, SW10 9NH
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Maraviroc (UK-427,857)
25 mg oral tablet once daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
50 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Experimental: B
Drug: Maraviroc (UK-427,857)
25 mg oral tablet once daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
50 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Experimental: C
Drug: Maraviroc (UK-427,857)
25 mg oral tablet once daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
50 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Experimental: D
Drug: Maraviroc (UK-427,857)
25 mg oral tablet once daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
50 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry
Placebo Comparator: E
Other: Placebo
Matching placebo oral tablet twice daily for 10 days
Other Names:
  • Celsentri, Selzentry

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical examination
Time Frame: Days 1, 11, 40
Days 1, 11, 40
Adverse events
Time Frame: Days 1-40
Days 1-40
12-lead electrocardiography
Time Frame: Days 1-11 and Day 40
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
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
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
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
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
Days 1-11
Laboratory safety testing
Time Frame: Days 1, 3, 7, 11, 15, 40
Days 1, 3, 7, 11, 15, 40
Supine and standing blood pressure and pulse rate
Time Frame: Days 1-11 and Day 40
Days 1-11 and Day 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4001007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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