Pioglitazone to Treat Fatty Liver in People With HIV Infection

This study has been completed.

Study NCT00441272 Information provided by National Institutes of Health Clinical Center (CC)

First Received on February 27, 2007. Last Updated on January 29, 2010 History of Changes

Results First Received: April 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	HIV Infections Hepatic Steatosis Insulin Resistance
Intervention:	Drug: Pioglitazone

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
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	Those participants receiving placebo for 48 weeks
Pioglitazone 45mg/Day	Those participants receiveing Pioglitazone 45mg/day for 48 weeks.

Participant Flow: Overall Study

	Placebo	Pioglitazone 45mg/Day
STARTED	25	25
COMPLETED	0 ^[1]	0 ^[1]
NOT COMPLETED	25	25
Study terminated prior to enrollment	25	25

[1]	Study terminated prior to enrollment.

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Those participants receiving placebo for 48 weeks
Pioglitazone 45mg/Day	Those participants receiveing Pioglitazone 45mg/day for 48 weeks.

Baseline Measures

	Placebo	Pioglitazone 45mg/Day	Total
Number of Participants [units: participants]	25	25	50
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	25	25	50
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	40 ± 5	40 ± 5	40 ± 5
Gender [units: participants]
Female	12	13	25
Male	13	12	25
Region of Enrollment [units: participants]
United States	25	25	50

Outcome Measures

1. Primary:

Hepatic Steatosis [ Time Frame: 96 weeks ]

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2. Secondary:

Insulin Resistance [ Time Frame: 48 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
Early termination prior to enrollment leading to no analysis of enrolled participants receiving Pioglitazone or placebo.

Results Point of Contact:

Name/Title: Colleen Hadigan, MD, MPH
Organization: National Institute of Allergy and Infectious Diseases
phone: 301-594-5754
e-mail: hadiganc@niaid.nih.gov

Publications:

Jain MK, Skiest DJ, Cloud JW, Jain CL, Burns D, Berggren RE. Changes in mortality related to human immunodeficiency virus infection: comparative analysis of inpatient deaths in 1995 and in 1999-2000. Clin Infect Dis. 2003 Apr 15;36(8):1030-8. Epub 2003 Apr 2.

Carr A, Samaras K, Chisholm DJ, Cooper DA. Pathogenesis of HIV-1-protease inhibitor-associated peripheral lipodystrophy, hyperlipidaemia, and insulin resistance. Lancet. 1998 Jun 20;351(9119):1881-3. Review.

Carr A, Miller J, Law M, Cooper DA. A syndrome of lipoatrophy, lactic acidaemia and liver dysfunction associated with HIV nucleoside analogue therapy: contribution to protease inhibitor-related lipodystrophy syndrome. AIDS. 2000 Feb 18;14(3):F25-32.

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
Study First Received:	February 27, 2007
Results First Received:	April 8, 2009
Last Updated:	January 29, 2010
Health Authority:	United States: Federal Government