Trial Outcomes & Findings for Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections (NCT NCT00742326)

NCT ID: NCT00742326

Last Updated: 2016-12-09

Results Overview

Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2016-12-09

Participant Flow

Participant milestones

Measure	Pioglitazone pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo Placebo once daily for 48 weeks
Overall Study STARTED	6	7
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Pioglitazone pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo Placebo once daily for 48 weeks
Overall Study Physician Decision	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pioglitazone n=6 Participants pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo n=7 Participants Placebo once daily for 48 weeks	Total n=13 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 5 • n=5 Participants	53 years STANDARD_DEVIATION 6 • n=7 Participants	52 years STANDARD_DEVIATION 6 • n=5 Participants
Gender Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Two subjects (one in each group) did not have a follow up MRI for comparision to baseline. One developed claustrophobia and could not tolerate MRI and one was discontinued from study due to other illnesses.

Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline

Outcome measures

Measure	Pioglitazone n=5 Participants pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo n=6 Participants Placebo once daily for 48 weeks
Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.	-7.43 percentage of hepatic fat on MRS Standard Deviation 4.6	-2.17 percentage of hepatic fat on MRS Standard Deviation 9.9

SECONDARY outcome

Timeframe: 48 weeks

Population: One subject in the placebo arm was discontinued due to health issues and does not have a 48 week OGTT available

Change in Glucose Area Under the Curve from standard oral glucose challenge ( baseline to 2 hours): Week 48 - Baseline values

Outcome measures

Measure	Pioglitazone n=6 Participants pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo n=6 Participants Placebo once daily for 48 weeks
Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo	-31 mg*120 minutes/dL Standard Deviation 29.2	11 mg*120 minutes/dL Standard Deviation 43.5

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pioglitazone n=6 participants at risk pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo n=7 participants at risk Placebo once daily for 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.00% 0/6 • 48 weeks of randomized study participation	14.3% 1/7 • Number of events 1 • 48 weeks of randomized study participation
Infections and infestations Dental Abscess	0.00% 0/6 • 48 weeks of randomized study participation	14.3% 1/7 • Number of events 1 • 48 weeks of randomized study participation
Renal and urinary disorders Renal Insufficiency	0.00% 0/6 • 48 weeks of randomized study participation	14.3% 1/7 • Number of events 1 • 48 weeks of randomized study participation

Other adverse events

Measure	Pioglitazone n=6 participants at risk pioglitazone 45 mg daily for 48 weeks Pioglitazone	Placebo n=7 participants at risk Placebo once daily for 48 weeks
General disorders Fatigue	16.7% 1/6 • Number of events 6 • 48 weeks of randomized study participation	28.6% 2/7 • Number of events 7 • 48 weeks of randomized study participation
Metabolism and nutrition disorders Weight Gain	33.3% 2/6 • Number of events 6 • 48 weeks of randomized study participation	14.3% 1/7 • Number of events 7 • 48 weeks of randomized study participation
Metabolism and nutrition disorders Decrease serum albumin	33.3% 2/6 • Number of events 6 • 48 weeks of randomized study participation	42.9% 3/7 • Number of events 7 • 48 weeks of randomized study participation
Endocrine disorders Increased cholesterol	16.7% 1/6 • Number of events 6 • 48 weeks of randomized study participation	28.6% 2/7 • Number of events 7 • 48 weeks of randomized study participation

Additional Information

Colleen Hadigan MD MPH

NIAID

Phone: 301-594-5754

Email: hadiganc@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60