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
  Purpose

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.


Condition Intervention Phase
HIV-1
Drug: UK-453,061
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: February 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 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
Experimental: Stage 2 Drug: UK-453,061
Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348673

Locations
Germany
Pfizer Investigational Site
Frankfurt am Main, Germany, 60590
Pfizer Investigational Site
Hamburg, Germany, 20099
Pfizer Investigational Site
Koeln, Germany, 50937
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00348673     History of Changes
Other Study ID Numbers: A5271010
Study First Received: July 5, 2006
Results First Received: August 14, 2013
Last Updated: August 14, 2013
Health Authority: Germany: Ministry of Health

ClinicalTrials.gov processed this record on October 23, 2014