A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

NCT00348673

Last updated date
Study Location
Pfizer Investigational Site
Frankfurt am Main, , 60590, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
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 and patients aged 18-55 years inclusive.

- Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

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


- Patients with a CD4 count less than 250 cells/mm3.


- Patients whose HIV infection has been diagnosed less than 3 months prior to screening,
or for whom there is evidence of recent seroconversion.


- Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor
v1.5).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Official Title  ICMJE A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Brief Summary A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE
  • Drug: UK-453,061
    Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days
  • Drug: UK-453,061
    Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days
Study Arms  ICMJE
  • Experimental: Stage 1
    Intervention: Drug: UK-453,061
  • Experimental: Stage 2
    Intervention: Drug: UK-453,061
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: May 14, 2013)
49
Original Enrollment  ICMJE
 (submitted: July 5, 2006)
40
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
  • Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

Exclusion Criteria:

  • Patients with a CD4 count less than 250 cells/mm3.
  • Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
  • Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).
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 NCT00348673
Other Study ID Numbers  ICMJE A5271010
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 ViiV Healthcare
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