Clinical trial NCT00634959: Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: HIV Infections
Treatment Naïve
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-03-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in viral load
timeFrame: Day 11
measure: UK-427,857 pharmacokinetics
timeFrame: Days 1-11
Secondary outcomes:
measure: Physical examination
timeFrame: Days 1, 11, 40
measure: 12-lead ECG
timeFrame: Days 1-11 and Day 40
measure: Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)
timeFrame: Days 1-11
measure: Time course of viral load from baseline to follow-up
timeFrame: Days 1-13 and Days 15, 19, 22, 25, 40
measure: CCR5 receptor saturation
timeFrame: Days 1, 5, 10, 11, 13, 15, 19, 40
measure: Adverse events
timeFrame: Days 1-40
measure: Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)
timeFrame: Days 1-11
measure: Laboratory safety
timeFrame: Days 1, 3, 7, 11, 15, 40
measure: Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)
timeFrame: Days 1-11
measure: Supine/standing blood pressure and pulse rate
timeFrame: Days 1-11 and Day 40
measure: Time to rebound of viral load
timeFrame: Days 1-13 and Days 15, 19, 22, 25, 40
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: