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Trial record 1 of 1 for:    NCT00495677
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A Phase 2 Study Of PF-00232798 In HIV Positive Patients

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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):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 29, 2007
First Posted Date  ICMJE July 3, 2007
Results First Submitted Date  ICMJE August 26, 2013
Results First Posted Date  ICMJE October 30, 2013
Last Update Posted Date October 30, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2007)
Viral load.
Change History Complete list of historical versions of study NCT00495677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
  • 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.
  • 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 ]
  • 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 ]
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2007)
Secondary: PF-00232798 steady state pharmacokinetics: Day 10 Cmax, Tmax, AUC24. PF-00232798 safety and toleration. Other: Viral resistance and tropism; CCR5Δ32 genotyping & immunophenotyping.
Current Other Pre-specified Outcome Measures
 (submitted: August 26, 2013)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study Of PF-00232798 In HIV Positive Patients
Official Title  ICMJE A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798
Brief Summary To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: PF-00232798
    Solution, 20 mg. once daily, 10 days
  • Drug: PF-00232798
    Solution, 150 mg. once daily, 10 days
  • Drug: PF-00232798
    Solution, 5 mg. once daily, 10 days
  • Drug: PF-00232798
    Solution, 40 mg. once daily, 10 days
  • Drug: PF-00232798
    Solution, 300 mg. once daily, 10 days
  • Drug: PF-00232798
    Solution, 400 mg. once daily, 10 days
Study Arms  ICMJE
  • Active Comparator: PF-00232798 40 mg
    Intervention: Drug: PF-00232798
  • Active Comparator: PF-00232798 300 mg
    Intervention: Drug: PF-00232798
  • Active Comparator: PF-00232798 400 mg
    Intervention: Drug: PF-00232798
  • Active Comparator: PF-00232798 5 mg
    Intervention: Drug: PF-00232798
  • Active Comparator: PF-00232798 20 mg
    Intervention: Drug: PF-00232798
  • Active Comparator: PF-00232798 150 mg
    Intervention: Drug: PF-00232798
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2011)
43
Original Enrollment  ICMJE
 (submitted: June 29, 2007)
20
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00495677
Other Study ID Numbers  ICMJE A7691009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP