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Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections

This study has been terminated.
(Enrollment stopped prior to complete enrollment due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00742326
First received: August 26, 2008
Last updated: October 26, 2016
Last verified: October 2016
Results First Received: April 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
Hepatitis C
Liver Disease
Fatty Liver
Steatosis
Interventions: Drug: Pioglitazone
Drug: Placebo

  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
Pioglitazone

pioglitazone 45 mg daily for 48 weeks

Pioglitazone

Placebo Placebo once daily for 48 weeks

Participant Flow:   Overall Study
    Pioglitazone   Placebo
STARTED   6   7 
COMPLETED   6   6 
NOT COMPLETED   0   1 
Physician Decision                0                1 



  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
Pioglitazone

pioglitazone 45 mg daily for 48 weeks

Pioglitazone

Placebo Placebo once daily for 48 weeks
Total Total of all reporting groups

Baseline Measures
   Pioglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   7   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (5)   53  (6)   52  (6) 
Gender 
[Units: Participants]
Count of Participants
     
Female      1  16.7%      3  42.9%      4  30.8% 
Male      5  83.3%      4  57.1%      9  69.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1  14.3%      1   7.7% 
Not Hispanic or Latino      6 100.0%      6  85.7%      12  92.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6 100.0%      6  85.7%      12  92.3% 
White      0   0.0%      1  14.3%      1   7.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.   [ Time Frame: 48 weeks ]

2.  Secondary:   Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo   [ Time Frame: 48 weeks ]


  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
The study failed to enroll to the originally established sample size due to slow enrollment.


  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: NIAID
phone: 301-594-5754
e-mail: hadiganc@niaid.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00742326     History of Changes
Other Study ID Numbers: 080201
Study First Received: August 26, 2008
Results First Received: April 10, 2014
Last Updated: October 26, 2016