Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00495677
First received: June 29, 2007
Last updated: August 26, 2013
Last verified: August 2013
  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:
  • Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 [ Time Frame: Baseline, Day 11 ] [ Designated as safety issue: No ]
    Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.


Secondary Outcome Measures:
  • Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load [ Time Frame: Day 1 up to Day 25 ] [ Designated as safety issue: No ]
    The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 ] [ Designated as safety issue: No ]
    AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).


Other Outcome Measures:
  • Number of Participants With Viral Tropism and Resistance [ Time Frame: Screening, pre-dose on Day 1; Day 11, 25 ] [ Designated as safety issue: No ]
    Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.

  • Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping [ Time Frame: Pre-dose on Day 1 ] [ Designated as safety issue: No ]
    CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Pfizer
ClinicalTrials.gov Identifier: NCT00495677     History of Changes
Other Study ID Numbers: A7691009
Study First Received: June 29, 2007
Results First Received: August 26, 2013
Last Updated: August 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:
Treatment Experienced
Treatment Naive

ClinicalTrials.gov processed this record on November 19, 2014