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Pioglitazone to Treat Fatty Liver in People With HIV Infection

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00441272
First received: February 27, 2007
Last updated: January 29, 2010
Last verified: October 2008
Results First Received: April 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Hepatic Steatosis
Insulin Resistance
Intervention: Drug: Pioglitazone

  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
Recruitment will occur in Clinic 8 of the Clinical Center. We anticipate needing to screen 100 subjects to identify a sufficient number to enroll in the study. Recruitment will be over approximately 1 year.

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 Those participants receiving placebo for 48 weeks
Pioglitazone 45mg/Day Those participants receiveing Pioglitazone 45mg/day for 48 weeks.

Participant Flow:   Overall Study
    Placebo   Pioglitazone 45mg/Day
STARTED   25   25 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   25   25 
Study terminated prior to enrollment                25                25 
[1] Study terminated prior to enrollment.



  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
Placebo Those participants receiving placebo for 48 weeks
Pioglitazone 45mg/Day Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Pioglitazone 45mg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   25   25   50 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 40  (5)   40  (5)   40  (5) 
Gender 
[Units: Participants]
     
Female   12   13   25 
Male   13   12   25 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures

1.  Primary:   Hepatic Steatosis   [ Time Frame: 96 weeks ]

2.  Secondary:   Insulin Resistance   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination prior to enrollment leading to no analysis of enrolled participants receiving Pioglitazone or placebo.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Colleen Hadigan, MD, MPH
Organization: National Institute of Allergy and Infectious Diseases
phone: 301-594-5754
e-mail: hadiganc@niaid.nih.gov


Publications:

Responsible Party: Colleen M. Hadigan, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00441272     History of Changes
Other Study ID Numbers: 070105
07-I-0105
Study First Received: February 27, 2007
Results First Received: April 8, 2009
Last Updated: January 29, 2010
Health Authority: United States: Federal Government