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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Page 1 of 1 (3 locations)

1

Pfizer Investigational Site

Cologne, Germany, 50937

2

Pfizer Investigational Site

Frankfurt am Main, Germany, 60590

3

Pfizer Investigational Site

Hamburg, Germany, 20099