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Trial record 29 of 31 for:    " February 14, 2007":" March 16, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Pioglitazone to Treat Fatty Liver in People With HIV Infection

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ClinicalTrials.gov Identifier: NCT00441272
Recruitment Status : Completed
First Posted : February 28, 2007
Results First Posted : February 19, 2010
Last Update Posted : February 19, 2010
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infections
Hepatic Steatosis
Insulin Resistance
Intervention Drug: Pioglitazone
Enrollment 100
Recruitment Details 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  
Arm/Group Title Placebo Pioglitazone 45mg/Day
Hide Arm/Group Description Those participants receiving placebo for 48 weeks Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
Period Title: Overall Study
Started 25 25
Completed 0 [1] 0 [1]
Not Completed 25 25
Reason Not Completed
Study terminated prior to enrollment             25             25
[1]
Study terminated prior to enrollment.
Arm/Group Title Placebo Pioglitazone 45mg/Day Total
Hide Arm/Group Description Those participants receiving placebo for 48 weeks Those participants receiveing Pioglitazone 45mg/day for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
25
 100.0%
25
 100.0%
50.0
>=65 years
0
   0.0%
0
   0.0%
0.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
40  (5) 40  (5) 40  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
12
  48.0%
13
  52.0%
25.0
Male
13
  52.0%
12
  48.0%
25.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Hepatic Steatosis
Hide Description Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.
Time Frame 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 11 subjects enrolled into the study. 10 were determined to be ineligible during the screening as the Computerized tomography scan revealed a liver-to-spleen ratio > 1 and one was determined ineligible due to concomitant medication use.
Arm/Group Title Placebo Pioglitazone 45mg/Day
Hide Arm/Group Description:
Those participants receiving placebo for 48 weeks
Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Insulin Resistance
Hide Description [Not Specified]
Time Frame 48 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pioglitazone 45mg/Day
Hide Arm/Group Description Those participants receiving placebo for 48 weeks Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
All-Cause Mortality
Placebo Pioglitazone 45mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pioglitazone 45mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pioglitazone 45mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Early termination prior to enrollment leading to no analysis of enrolled participants receiving Pioglitazone or placebo.
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
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
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: April 8, 2009
Results First Posted: February 19, 2010
Last Update Posted: February 19, 2010