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

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00348673
First received: July 5, 2006
Last updated: August 14, 2013
Last verified: August 2013

July 5, 2006
August 14, 2013
February 2006
February 2007   (final data collection date for primary outcome measure)
Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 [ Time Frame: Baseline, Day 8 ] [ Designated as safety issue: No ]
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.
  • 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
Complete list of historical versions of study NCT00348673 on ClinicalTrials.gov Archive Site
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]) ] [ Designated as safety issue: No ]
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.
  • 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
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
 
A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV-1
  • 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
  • Experimental: Stage 1
    Intervention: Drug: UK-453,061
  • Experimental: Stage 2
    Intervention: Drug: UK-453,061
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
February 2007
February 2007   (final data collection date for primary outcome measure)

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).
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00348673
A5271010
No
Pfizer
Pfizer
ViiV Healthcare
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