Clinical trial NCT00643643: Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Official title: A Randomised, Double Blind, Placebo-Controlled, Multicentre Study Of UK-427,857 25mg O.D. , 50mg B.I.D., 100mg B.I.D And 300mg B.I.D. In Asymptomatic HIV Infected Patients To Investigate Pharmacodynamics, Pharmacokinetics, Safety And Toleration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
Treatment Naïve
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-03-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in viral load
timeFrame: Day 11
measure: Pharmacokinetic profile of UK-427,857
timeFrame: Days 1 and 10
measure: Receptor saturation
timeFrame: Days 1, 5, 10, 11, 13, 15, 19, 40
Secondary outcomes:
measure: 12-lead electrocardiography
timeFrame: Days 1-11 and Day 40
measure: Time course of viral load from baseline to follow-up
timeFrame: Days 1-15 and Days 19, 22, 25, 40
measure: Time to rebound of viral load
timeFrame: Days 1-15 and Days 19, 22, 25, 40
measure: The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations
timeFrame: Days 1-11
measure: The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)
timeFrame: Days 1-11
measure: The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)
timeFrame: Days 1-11
measure: Adverse events
timeFrame: Days 1-40
measure: Laboratory safety testing
timeFrame: Days 1, 3, 7, 11, 15, 40
measure: Physical examination
timeFrame: Days 1, 11, 40
measure: Supine and standing blood pressure and pulse rate
timeFrame: Days 1-11 and Day 40
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
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: