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

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NCT00495677

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Study Location
Pfizer Investigational Site
Frankfurt am Main, , 60590, Germany
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Contact
1-800-718-1021
Clinica[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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HIVA Phase 2 Study Of PF-00232798 In HIV Positive Patients NCT00495677
  1. Frankfurt am Main,
  2. Koeln,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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