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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643643
• Other study ID #: A4001007
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: November 9, 2010
• Start date: October 2002
• Est. completion date: June 2003

Study information

• Verified date: November 2010
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: EMEA
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Maraviroc (UK-427,857)
25 mg oral tablet once daily for 10 days
• Maraviroc (UK-427,857)
50 mg oral tablet twice daily for 10 days
• Maraviroc (UK-427,857)
100 mg oral tablet twice daily for 10 days
• Maraviroc (UK-427,857)
300 mg oral tablet twice daily for 10 days

Other:
• Placebo
Matching placebo oral tablet twice daily for 10 days

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Muenchen
Netherlands	Pfizer Investigational Site	Utrecht
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in viral load		Day 11	No
Primary	Pharmacokinetic profile of UK-427,857		Days 1 and 10	No
Primary	Receptor saturation		Days 1, 5, 10, 11, 13, 15, 19, 40	No
Secondary	12-lead electrocardiography		Days 1-11 and Day 40	Yes
Secondary	Time course of viral load from baseline to follow-up		Days 1-15 and Days 19, 22, 25, 40	No
Secondary	Time to rebound of viral load		Days 1-15 and Days 19, 22, 25, 40	No
Secondary	The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations		Days 1-11	No
Secondary	The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)		Days 1-11	No
Secondary	The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)		Days 1-11	No
Secondary	Adverse events		Days 1-40	Yes
Secondary	Laboratory safety testing		Days 1, 3, 7, 11, 15, 40	Yes
Secondary	Physical examination		Days 1, 11, 40	Yes
Secondary	Supine and standing blood pressure and pulse rate		Days 1-11 and Day 40	Yes

External Links

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