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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643643

Enrollment

Registered

2008-03-26

Start date

2002-10-31

Completion date

2003-06-30

Last updated

2010-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Treatment Naïve

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).

Interventions

DRUGMaraviroc (UK-427,857)

25 mg oral tablet once daily for 10 days

OTHERPlacebo

Matching placebo oral tablet twice daily for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)	Days 1-11
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
12-lead electrocardiography	Days 1-11 and Day 40
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

Countries

Germany, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026