Overview

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

Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Treatments:
Maraviroc
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