We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00495677
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
HIV Drug: PF-00232798 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 [ Time Frame: Baseline, Day 11 ]
    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 :
  1. Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load [ Time Frame: Day 1 up to Day 25 ]
    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.

  2. 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 ]
  3. 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 ]
  4. 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 ]
    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:
  1. Number of Participants With Viral Tropism and Resistance [ Time Frame: Screening, pre-dose on Day 1; Day 11, 25 ]
    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.

  2. Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping [ Time Frame: Pre-dose on Day 1 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00495677     History of Changes
Other Study ID Numbers: A7691009
First Posted: July 3, 2007    Key Record Dates
Results First Posted: October 30, 2013
Last Update Posted: October 30, 2013
Last Verified: August 2013

Keywords provided by Pfizer:
Treatment Experienced
Treatment Naive