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

Tracking Information

First Received Date ^ICMJE

March 19, 2008

Last Updated Date

November 9, 2010

Start Date ^ICMJE

October 2002

Primary Completion Date

June 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00643643 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2003

Primary Completion Date

June 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany, Netherlands, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00643643

Other Study ID Numbers ^ICMJE

A4001007

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc

Study Sponsor ^ICMJE

ViiV Healthcare

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

ViiV Healthcare

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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