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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Maraviroc (UK-427,857); Other: Placebo

• Registration Number: NCT00643643
• Lead Sponsor: ViiV Healthcare

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 available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-26
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D	Maraviroc (UK-427,857)	-
A	Maraviroc (UK-427,857)	-
B	Maraviroc (UK-427,857)	-
C	Maraviroc (UK-427,857)	-
E	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
12-lead electrocardiography	Days 1-11 and Day 40
Time course of viral load from baseline to follow-up	Days 1-15 and Days 19, 22, 25, 40
Time to rebound of viral load	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	Days 1-11
The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)	Days 1-11
The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)	Days 1-11
Adverse events	Days 1-40
Laboratory safety testing	Days 1, 3, 7, 11, 15, 40
Physical examination	Days 1, 11, 40
Supine and standing blood pressure and pulse rate	Days 1-11 and Day 40

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom