Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

Phase 2

Completed

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

• Registration Number: NCT00634959
• Lead Sponsor: ViiV Healthcare

Brief Summary

To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study Completion: 2003-12
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-13
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Asymptomatic HIV-1 infected male and female patients
• Weight between 50 and 100kg and within the permitted range for their height
• Patients with virus that targets CCR5 receptor

Exclusion Criteria

• Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
• Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
• Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
• Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Maraviroc (UK-427,857)	-
1	Maraviroc (UK-427,857)	-
2	Maraviroc (UK-427,857)	-
4	Maraviroc (UK-427,857)	-
5	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in viral load	Day 11
UK-427,857 pharmacokinetics	Days 1-11

Secondary Outcome Measures

Name	Time	Method
Physical examination	Days 1, 11, 40
12-lead ECG	Days 1-11 and Day 40
Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)	Days 1-11
Time course of viral load from baseline to follow-up	Days 1-13 and Days 15, 19, 22, 25, 40
CCR5 receptor saturation	Days 1, 5, 10, 11, 13, 15, 19, 40
Adverse events	Days 1-40
Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)	Days 1-11
Laboratory safety	Days 1, 3, 7, 11, 15, 40
Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)	Days 1-11
Supine/standing blood pressure and pulse rate	Days 1-11 and Day 40
Time to rebound of viral load	Days 1-13 and Days 15, 19, 22, 25, 40

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom