Status:
COMPLETED
A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Lead Sponsor:
Pfizer
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-1
Eligibility:
MALE
18-55 years
Phase:
PHASE2
Brief Summary
A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response ...
Eligibility Criteria
Inclusion
- Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
- Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.
Exclusion
- Patients with a CD4 count less than 250 cells/mm3.
- Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
- Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00348673
Start Date
February 1 2006
End Date
February 1 2007
Last Update
October 18 2013
Active Locations (3)
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1
Pfizer Investigational Site
Cologne, Germany, 50937
2
Pfizer Investigational Site
Frankfurt am Main, Germany, 60590
3
Pfizer Investigational Site
Hamburg, Germany, 20099