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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Frankfurt am Main, , 60590 Germany
Contact
1-800-718-1021
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.

NCT00495677
Pfizer
Completed
A Phase 2 Study Of PF-00232798 In HIV Positive Patients

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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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00495677
A7691009
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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