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HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) (HAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01023620
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition HIV Infections
Interventions Drug: Pioglitazone
Other: Observation
Enrollment 4
Recruitment Details  
Pre-assignment Details No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Arm/Group Title Pioglitazone Observation/Comparison
Hide Arm/Group Description

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

10 male patients with lipodystrophy not taking daily Pioglitazone

Observation: Participants will be observed for 16 weeks but will not receive drug

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Pioglitazone Observation/Comparison Total
Hide Arm/Group Description

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

10 male patients with lipodystrophy not taking daily Pioglitazone

Observation: Participants will be observed for 16 weeks but will not receive drug

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
0 Participants  
Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
Hide Description No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed
Arm/Group Title Pioglitazone Observation/Comparison
Hide Arm/Group Description:

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

10 male patients with lipodystrophy not taking daily Pioglitazone

Observation: Participants will be observed for 16 weeks but will not receive drug

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Investigator left the university mid way through the study and unable to find him.
Arm/Group Title Pioglitazone Observation/Comparison
Hide Arm/Group Description:

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

10 male patients with lipodystrophy not taking daily Pioglitazone

Observation: Participants will be observed for 16 weeks but will not receive drug

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed
Adverse Event Reporting Description No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed
 
Arm/Group Title Pioglitazone Observation/Comparison
Hide Arm/Group Description

10 male patients with lipodystrophy taking daily Pioglitazone 45 mg

Pioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.

10 male patients with lipodystrophy not taking daily Pioglitazone

Observation: Participants will be observed for 16 weeks but will not receive drug

All-Cause Mortality
Pioglitazone Observation/Comparison
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pioglitazone Observation/Comparison
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone Observation/Comparison
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Limerick
Organization: UT Southwestern Medical Center
Phone: 214-590-0611
EMail: Michael.Limerick@UTSouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01023620    
Other Study ID Numbers: Takeda IISR - MSA-PIO-028
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: March 8, 2019
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019