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

June 29, 2007
August 26, 2013
June 2007
September 2008   (final data collection date for primary outcome measure)
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.
Viral load.
Complete list of historical versions of study NCT00495677 on ClinicalTrials.gov Archive Site
  • 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).
Secondary: PF-00232798 steady state pharmacokinetics: Day 10 Cmax, Tmax, AUC24. PF-00232798 safety and toleration. Other: Viral resistance and tropism; CCR5Δ32 genotyping & immunophenotyping.
  • 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.
Not Provided
 
A Phase 2 Study Of PF-00232798 In HIV Positive Patients
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00495677
A7691009
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

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