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

Tracking Information
First Submitted Date ICMJE	March 19, 2008
First Posted Date ICMJE	March 26, 2008
Last Update Posted Date	November 10, 2010
Study Start Date ICMJE	October 2002
Actual Primary Completion Date	June 2003 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 19, 2008)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00643643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 19, 2008)	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 ]; Physical examination [ Time Frame: Days 1, 11, 40 ]; Supine and standing blood pressure and pulse rate [ Time Frame: Days 1-11 and Day 40 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Official Title ICMJE	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.
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).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	HIV Infections
Intervention ICMJE	Drug: Maraviroc (UK-427,857) 25 mg oral tablet once daily for 10 days Other Name: Celsentri, Selzentry; Drug: Maraviroc (UK-427,857) 50 mg oral tablet twice daily for 10 days Other Name: Celsentri, Selzentry; Drug: Maraviroc (UK-427,857) 100 mg oral tablet twice daily for 10 days Other Name: Celsentri, Selzentry; Drug: Maraviroc (UK-427,857) 300 mg oral tablet twice daily for 10 days Other Name: Celsentri, Selzentry; Other: Placebo Matching placebo oral tablet twice daily for 10 days Other Name: Celsentri, Selzentry
Study Arms	Experimental: A Intervention: Drug: Maraviroc (UK-427,857); Experimental: B Intervention: Drug: Maraviroc (UK-427,857); Experimental: C Intervention: Drug: Maraviroc (UK-427,857); Experimental: D Intervention: Drug: Maraviroc (UK-427,857); Placebo Comparator: E Intervention: Other: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 19, 2008)	41
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2003
Actual Primary Completion Date	June 2003 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany, Netherlands, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00643643
Other Study ID Numbers ICMJE	A4001007
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor ICMJE	ViiV Healthcare
Collaborators ICMJE	Pfizer
Investigators ICMJE	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	ViiV Healthcare
Verification Date	November 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP