Trial to Study Ability to Reduce Viral Load and to Assess Safety and Toleration of UK 453,061 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00348673

Purpose

Trial to study ability to reduce viral load and to assess safety and toleration of UK-453,061

Condition	Intervention	Phase
HIV	Drug: UK-453,061	Phase II

MedlinePlus related topics: AIDS

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Pharmacodynamics Study
Official Title:	A Randomized, Double Blind, Placebo-Controlled, Multicenter, Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453-061

Further study details as provided by Pfizer:

Primary Outcome Measures:

Investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic HIV infected patients and to assess the dose-response relationship
Assess the pharmacokinetics, safety and tolerability of UK-453,061 in asymptomatic HIV inf

Secondary Outcome Measures:

UK-453,061 steady state pharmacokinetics, safety endpoints including adverse events, vital signs, ECGs and laboratory data
Viral resistance/viral genotyping

Estimated Enrollment:	40
Study Start Date:	February 2006

Eligibility

Criteria

Inclusion Criteria:

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 assay

Exclusion Criteria:

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 (Roch Amplicor v1.5)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348673

Locations

Germany
Pfizer Investigational Site
Koeln, Germany
Pfizer Investigational Site
Hamburg, Germany
Pfizer Investigational Site
Frankfurt am Main, Germany

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Study ID Numbers:	A5271010
Study First Received:	July 5, 2006
Last Updated:	March 6, 2007
ClinicalTrials.gov Identifier:	NCT00348673
Health Authority:	United Kingdom: Department of Health

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 14, 2009