A Phase 2 Study Of PF-00232798 In HIV Positive Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00495677
First received: June 29, 2007
Last updated: April 21, 2011
Last verified: April 2011
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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: | 43 |
| 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 |
|---|---|
| Active Comparator: PF-00232798 40 mg |
Drug: PF-00232798
Solution, 40 mg. once daily, 10 days
|
| Active Comparator: PF-00232798 300 mg |
Drug: PF-00232798
Solution, 300 mg. once daily, 10 days
|
| Active Comparator: PF-00232798 400 mg |
Drug: PF-00232798
Solution, 400 mg. once daily, 10 days
|
| Active Comparator: PF-00232798 5 mg |
Drug: PF-00232798
Solution, 5 mg. once daily, 10 days
|
| Active Comparator: PF-00232798 20 mg |
Drug: PF-00232798
Solution, 20 mg. once daily, 10 days
|
| Active Comparator: PF-00232798 150 mg |
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 | |
| Frankfurt am Main, Germany, 60590 | |
| Pfizer Investigational Site | |
| Koeln, Germany, 50937 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00495677 History of Changes |
| Other Study ID Numbers: | A7691009 |
| Study First Received: | June 29, 2007 |
| Last Updated: | April 21, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Pfizer:
|
Treatment Experienced Treatment Naive |
ClinicalTrials.gov processed this record on May 22, 2013