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
Results First Received: August 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV-1
Intervention: Drug: UK-453,061

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
Placebo Once/Twice Daily (Stage 1) Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 750 mg Once Daily (Stage 2) Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
UK-453,061 500 mg Twice Daily (Stage 2) Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
UK-453,061 100 mg Once Daily (Stage 2) Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Placebo Once/Twice Daily (Stage 2) Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.

Participant Flow for 2 periods

Period 1:   Stage 1
    UK-453,061 10 mg Twice Daily (Stage 1)     UK-453,061 30 mg Twice Daily (Stage 1)     UK-453,061 100 mg Twice Daily (Stage 1)     UK-453,061 500 mg Once Daily (Stage 1)     Placebo Once/Twice Daily (Stage 1)     UK-453,061 750 mg Once Daily (Stage 2)     UK-453,061 500 mg Twice Daily (Stage 2)     UK-453,061 100 mg Once Daily (Stage 2)     Placebo Once/Twice Daily (Stage 2)  
STARTED     6     6     7     6     4     0     0     0     0  
Treated     6     6     6     6     4     0     0     0     0  
COMPLETED     6     6     6     6     4     0     0     0     0  
NOT COMPLETED     0     0     1     0     0     0     0     0     0  
Randomized but not Treated                 0                 0                 1                 0                 0                 0                 0                 0                 0  

Period 2:   Stage 2
    UK-453,061 10 mg Twice Daily (Stage 1)     UK-453,061 30 mg Twice Daily (Stage 1)     UK-453,061 100 mg Twice Daily (Stage 1)     UK-453,061 500 mg Once Daily (Stage 1)     Placebo Once/Twice Daily (Stage 1)     UK-453,061 750 mg Once Daily (Stage 2)     UK-453,061 500 mg Twice Daily (Stage 2)     UK-453,061 100 mg Once Daily (Stage 2)     Placebo Once/Twice Daily (Stage 2)  
STARTED     0     0     0     0     0     6     6     6     2  
COMPLETED     0     0     0     0     0     6     6     6     2  
NOT COMPLETED     0     0     0     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
UK-453,061 10 mg Twice Daily (Stage 1) UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 30 mg Twice Daily (Stage 1) UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 100 mg Twice Daily (Stage 1) UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
UK-453,061 500 mg Once Daily (Stage 1) UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
UK-453,061 750 mg Once Daily (Stage 2) Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
UK-453,061 500 mg Twice Daily (Stage 2) Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
UK-453,061 100 mg Once Daily (Stage 2) Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
Placebo Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
Total Total of all reporting groups

Baseline Measures
    UK-453,061 10 mg Twice Daily (Stage 1)     UK-453,061 30 mg Twice Daily (Stage 1)     UK-453,061 100 mg Twice Daily (Stage 1)     UK-453,061 500 mg Once Daily (Stage 1)     UK-453,061 750 mg Once Daily (Stage 2)     UK-453,061 500 mg Twice Daily (Stage 2)     UK-453,061 100 mg Once Daily (Stage 2)     Placebo     Total  
Number of Participants  
[units: participants]
  6     6     6     6     6     6     6     6     48  
Age  
[units: years]
Mean ± Standard Deviation
  38.8  ± 8.4     38.2  ± 8.6     33.5  ± 8.6     41.7  ± 4.1     29.2  ± 7.9     40.3  ± 7.5     37.0  ± 8.5     33.8  ± 8.0     36.6  ± 8.2  
Gender  
[units: participants]
                 
Female     0     0     0     0     0     0     0     0     0  
Male     6     6     6     6     6     6     6     6     48  



  Outcome Measures
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1.  Primary:   Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8   [ Time Frame: Baseline, Day 8 ]

2.  Secondary:   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]) ]

3.  Other Pre-specified:   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 ]

4.  Other Pre-specified:   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 ]

5.  Other Pre-specified:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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