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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Maraviroc (UK-427,857)

Placebo

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Naïve

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in viral load

Pharmacokinetic profile of UK-427,857

Receptor saturation

Secondary Outcome Measures

12-lead electrocardiography

Time course of viral load from baseline to follow-up

Time to rebound of viral load

The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations

The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)

The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)

Adverse events

Laboratory safety testing

Physical examination

Supine and standing blood pressure and pulse rate

Full Information

NCT ID

NCT00643643

First Posted

March 19, 2008

Last Updated

November 9, 2010

Sponsor

ViiV Healthcare

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00643643

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ViiV Healthcare

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, Treatment Naïve

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Maraviroc (UK-427,857)

Other Intervention Name(s)

Celsentri, Selzentry

Intervention Description

25 mg oral tablet once daily for 10 days

Intervention Type

Drug

Intervention Name(s)

Maraviroc (UK-427,857)

Other Intervention Name(s)

Celsentri, Selzentry

Intervention Description

50 mg oral tablet twice daily for 10 days

Intervention Type

Drug

Intervention Name(s)

Maraviroc (UK-427,857)

Other Intervention Name(s)

Celsentri, Selzentry

Intervention Description

100 mg oral tablet twice daily for 10 days

Intervention Type

Drug

Intervention Name(s)

Maraviroc (UK-427,857)

Other Intervention Name(s)

Celsentri, Selzentry

Intervention Description

300 mg oral tablet twice daily for 10 days

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Celsentri, Selzentry

Intervention Description

Matching placebo oral tablet twice daily for 10 days

Primary Outcome Measure Information:

Title

Change from baseline in viral load

Time Frame

Day 11

Title

Pharmacokinetic profile of UK-427,857

Time Frame

Days 1 and 10

Title

Receptor saturation

Time Frame

Days 1, 5, 10, 11, 13, 15, 19, 40

Secondary Outcome Measure Information:

Title

12-lead electrocardiography

Time Frame

Days 1-11 and Day 40

Title

Time course of viral load from baseline to follow-up

Time Frame

Days 1-15 and Days 19, 22, 25, 40

Title

Time to rebound of viral load

Time Frame

Days 1-15 and Days 19, 22, 25, 40

Title

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

Title

The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)

Time Frame

Days 1-11

Title

The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)

Time Frame

Days 1-11

Title

Adverse events

Time Frame

Days 1-40

Title

Laboratory safety testing

Time Frame

Days 1, 3, 7, 11, 15, 40

Title

Physical examination

Time Frame

Days 1, 11, 40

Title

Supine and standing blood pressure and pulse rate

Time Frame

Days 1-11 and Day 40

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Pfizer Investigational Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001007&StudyName=Pharmacokinetics%2C%20Pharmacodynamics%2C%20And%20Safety%20Of%20Maraviroc%20%28UK-427%2C857%29%20In%20Patients%20With%20Human%20Immunodeficiency%20Virus

Description

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

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