Trial Outcomes & Findings for Pioglitazone to Treat Fatty Liver in People With HIV Infection (NCT NCT00441272)

Results Overview

Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

96 weeks

Results posted on

2010-02-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Placebo Those participants receiving placebo for 48 weeks	Pioglitazone 45mg/Day Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
Overall Study STARTED	25	25
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Those participants receiving placebo for 48 weeks	Pioglitazone 45mg/Day Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
Overall Study Study terminated prior to enrollment	25	25

Baseline Characteristics

Pioglitazone to Treat Fatty Liver in People With HIV Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=25 Participants Those participants receiving placebo for 48 weeks	Pioglitazone 45mg/Day n=25 Participants Those participants receiveing Pioglitazone 45mg/day for 48 weeks.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50.0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age Continuous	40 years STANDARD_DEVIATION 5 • n=5 Participants	40 years STANDARD_DEVIATION 5 • n=7 Participants	40 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25.0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25.0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50.0 participants n=5 Participants

PRIMARY outcome

Timeframe: 96 weeks

Population: 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.

Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pioglitazone 45mg/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Colleen Hadigan, MD, MPH

National Institute of Allergy and Infectious Diseases

Phone: 301-594-5754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place