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: May 15, 2014
Last verified: May 2014
Results First Received: April 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
Hepatitis C
Liver Disease
Fatty Liver
Steatosis
Intervention: Drug: Pioglitazone

  Participant Flow
  Hide Participant Flow

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

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



  Baseline Characteristics
  Hide Baseline Characteristics

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 No text entered.
Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Placebo     Total  
Number of Participants  
[units: participants]
  6     7     13  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 5     53  ± 6     52  ± 6  
Gender  
[units: participants]
     
Female     1     3     4  
Male     5     4     9  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     6     12  
White     0     1     1  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     1     1  
Not Hispanic or Latino     6     6     12  
Unknown or Not Reported     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
  Hide 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
The study failed to enroll to the originally established sample size due to slow enrollment.


  More Information
  Hide More Information

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, 08-I-0201, NIH Intramural
Study First Received: August 26, 2008
Results First Received: April 10, 2014
Last Updated: May 15, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration