A Phase 2 Study Of PF-00232798 In HIV Positive Patients - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00495677

Purpose

To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.

Condition	Intervention	Phase
HIV	Drug: PF-00232798	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Pharmacodynamics Study
Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798

Further study details as provided by Pfizer:

Primary Outcome Measures:

Viral load. [ Time Frame: 22 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary: PF-00232798 steady state pharmacokinetics: Day 10 Cmax, Tmax, AUC24. PF-00232798 safety and toleration. Other: Viral resistance and tropism; CCR5Δ32 genotyping and immunophenotyping. [ Time Frame: end of trial ] [ Designated as safety issue: No ]

Enrollment:	23
Study Start Date:	June 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-00232798 40 mg: Active Comparator	Drug: PF-00232798 Solution, 40 mg. once daily, 10 days
PF-00232798 300 mg: Active Comparator	Drug: PF-00232798 Solution, 300 mg. once daily, 10 days
PF-00232798 400 mg: Active Comparator	Drug: PF-00232798 Solution, 400 mg. once daily, 10 days
PF-00232798 5 mg: Active Comparator	Drug: PF-00232798 Solution, 5 mg. once daily, 10 days
PF-00232798 20 mg: Active Comparator	Drug: PF-00232798 Solution, 20 mg. once daily, 10 days
PF-00232798 150 mg: Active Comparator	Drug: PF-00232798 Solution, 150 mg. once daily, 10 days

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years inclusive.
Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay.

Exclusion Criteria:

Patients who have received any experimental drug within the past four months (prior to the first dosing day of the study) or who have previously received another CCR5 antagonist.
Patients with evidence of decompensated liver disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495677

Locations

Germany
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Frankfurt am Main, Germany, 60590

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7691009
Study First Received:	June 29, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00495677
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:

Treatment Experienced
Treatment Naive

Study placed in the following topic categories:

HIV Seropositivity
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 16, 2009