Status:
COMPLETED
Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00643643
Start Date
October 1 2002
End Date
June 1 2003
Last Update
November 10 2010
Active Locations (6)
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1
Pfizer Investigational Site
Bonn, Germany, 53105
2
Pfizer Investigational Site
Cologne, Germany, 50924
3
Pfizer Investigational Site
München, Germany, 80336
4
Pfizer Investigational Site
Utrecht, Netherlands, 3584 CX