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

An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00634959

Enrollment

Registered

2008-03-13

Start date

2003-07-31

Completion date

2003-12-31

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

Keywords

HIV Infections, Treatment Naïve

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)

Interventions

DRUGMaraviroc (UK-427,857)

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

OTHERPlacebo

Matching placebo oral tablet on Days 1-10 (fed and fasted)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Physical examination	Days 1, 11, 40
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
Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)	Days 1-11
12-lead ECG	Days 1-11 and Day 40

Countries

Germany, United Kingdom, United States

Outcome results

None listed

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