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Trial record 1 of 1 for:    NCT00348673
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A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

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ClinicalTrials.gov Identifier: NCT00348673
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 5, 2006
First Posted Date  ICMJE July 6, 2006
Results First Submitted Date  ICMJE August 14, 2013
Results First Posted Date  ICMJE October 18, 2013
Last Update Posted Date October 18, 2013
Study Start Date  ICMJE February 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2013)
Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 [ Time Frame: Baseline, Day 8 ]
Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
  • Investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic HIV infected patients and to assess the dose-response relationship
  • Assess the pharmacokinetics, safety and tolerability of UK-453,061 in asymptomatic HIV inf
Change History Complete list of historical versions of study NCT00348673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2013)
Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load [ Time Frame: Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose]) ]
Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
  • Investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic HIV infected patients and to assess the dose-response relationship
  • Assess the pharmacokinetics, safety and tolerability of UK-453,061 in asymptomatic HIV infected patients
Current Other Pre-specified Outcome Measures
 (submitted: August 14, 2013)
  • Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 ]
    AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.
  • Maximum Observed Plasma Concentration at Steady State (Cmax,ss) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 ]
  • Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 ]
Original Other Pre-specified Outcome Measures Not Provided
 
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 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