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  
Number of Participants  
[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 posted.   Anticipated Posting 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