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

ViiV Healthcare37 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV

Interventions

Maraviroc (UK-427,857)DRUG

150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)

Maraviroc (UK-427,857)DRUG

100 mg oral tablet once daily while fasted on Days 1-10

Maraviroc (UK-427,857)DRUG

300 mg oral tablet once daily while fasted on Days 1-10

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (7)

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Boston, Massachusetts, United States

Pfizer Investigational Site

Cologne, Germany

Pfizer Investigational Site

Frankfurt, Germany

Outcomes

Primary Outcomes

Change from baseline in viral load

Time frame: Day 11

UK-427,857 pharmacokinetics

Time frame: Days 1-11

Secondary Outcomes

Physical examination

Time frame: Days 1, 11, 40

12-lead ECG

Time frame: Days 1-11 and Day 40

Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)

Time frame: Days 1-11

Time course of viral load from baseline to follow-up

Time frame: Days 1-13 and Days 15, 19, 22, 25, 40

CCR5 receptor saturation

Time frame: Days 1, 5, 10, 11, 13, 15, 19, 40

Adverse events

Time frame: Days 1-40

Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)

Time frame: Days 1-11

Laboratory safety

Time frame: 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)

Time frame: Days 1-11

Supine/standing blood pressure and pulse rate

Data from ClinicalTrials.gov

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