A Phase 2 Study Of PF-00232798 In HIV Positive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00495677
First received: June 29, 2007
Last updated: August 26, 2013
Last verified: August 2013
Results First Received: August 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: PF-00232798

  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
Placebo Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 5 mg Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 20 mg Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 150 mg Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 40 mg Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
PF-00232798 300 mg Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
PF-00232798 400 mg Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.

Participant Flow for 2 periods

Period 1:   Stage 1 (25 Days)
    Placebo     PF-00232798 5 mg     PF-00232798 20 mg     PF-00232798 150 mg     PF-00232798 40 mg     PF-00232798 300 mg     PF-00232798 400 mg  
STARTED     2     6     6     6     0     0     0  
COMPLETED     2     6     5     6     0     0     0  
NOT COMPLETED     0     0     1     0     0     0     0  
Adverse Event                 0                 0                 1                 0                 0                 0                 0  

Period 2:   Stage 2 (25 Days)
    Placebo     PF-00232798 5 mg     PF-00232798 20 mg     PF-00232798 150 mg     PF-00232798 40 mg     PF-00232798 300 mg     PF-00232798 400 mg  
STARTED     0     0     0     0     8     8     7  
COMPLETED     0     0     0     0     8     8     7  
NOT COMPLETED     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
PF-00232798 5 mg Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 20 mg Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 40 mg Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
PF-00232798 150 mg Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
PF-00232798 300 mg Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
PF-00232798 400mg Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Placebo Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Total Total of all reporting groups

Baseline Measures
    PF-00232798 5 mg     PF-00232798 20 mg     PF-00232798 40 mg     PF-00232798 150 mg     PF-00232798 300 mg     PF-00232798 400mg     Placebo     Total  
Number of Participants  
[units: participants]
  6     6     8     6     8     7     2     43  
Age  
[units: years]
Mean ± Standard Deviation
  31.5  ± 8.9     39.8  ± 8.5     36.5  ± 5.4     36.2  ± 9.1     36.1  ± 9.6     32.9  ± 5     29  ± 5.7     35.2  ± 7.8  
Gender  
[units: participants]
               
Female     0     0     0     0     0     0     0     0  
Male     6     6     8     6     8     7     2     43  



  Outcome Measures
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1.  Primary:   Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11   [ Time Frame: Baseline, Day 11 ]

2.  Secondary:   Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load   [ Time Frame: Day 1 up to Day 25 ]

3.  Secondary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning ]

4.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning ]

5.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)   [ Time Frame: 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 ]

6.  Other Pre-specified:   Number of Participants With Viral Tropism and Resistance   [ Time Frame: Screening, pre-dose on Day 1; Day 11, 25 ]

7.  Other Pre-specified:   Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping   [ Time Frame: Pre-dose on Day 1 ]


  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: NCT00495677     History of Changes
Other Study ID Numbers: A7691009
Study First Received: June 29, 2007
Results First Received: August 26, 2013
Last Updated: August 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices