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

ViiV Healthcare41 enrolled

Overview

To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV Infections

Interventions

Maraviroc (UK-427,857)DRUG

25 mg oral tablet once daily for 10 days

Maraviroc (UK-427,857)DRUG

50 mg oral tablet twice daily for 10 days

Maraviroc (UK-427,857)DRUG

100 mg oral tablet twice daily for 10 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (6)

Pfizer Investigational Site

Bonn, Germany

Pfizer Investigational Site

Cologne, Germany

Pfizer Investigational Site

München, Germany

Pfizer Investigational Site

Utrecht, Netherlands

Outcomes

Primary Outcomes

Change from baseline in viral load

Time frame: Day 11

Pharmacokinetic profile of UK-427,857

Time frame: Days 1 and 10

Receptor saturation

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

Secondary Outcomes

12-lead electrocardiography

Time frame: Days 1-11 and Day 40

Time course of viral load from baseline to follow-up

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

Time to rebound of viral load

Time frame: 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

Time frame: Days 1-11

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

Time frame: Days 1-11

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

Time frame: Days 1-11

Adverse events

Time frame: Days 1-40

Laboratory safety testing

Time frame: Days 1, 3, 7, 11, 15, 40

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.