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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01023620
• Collaborator: Takeda Pharmaceuticals North America, Inc. (Industry)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy.

Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region. They also more likely to have problems with insulin in the body, high fat levels in the blood and diabetes. The reason that lipodystrophy develops is not fully understood although some HIV drugs have are very likely the cause. The complications pose an increased risk of fat blockage forming in the arteries making you more at risk for heart problems in the future. Changes in body fat can cause physical discomfort and psychological distress. Management of these problems can be a challenge for the patient's doctor.

The investigators propose data collection to determine if there is more than one reason why this might happen in some people and not in others. Laboratory samples being collected: 1) special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the patient's body is handling the virus.

This study is being done because science does not fully understand why some patients with HIV who take medicines for the virus have abnormal fat loss or gain and some do not. This research study is intended to help us better understand why and how this happens.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Pioglitazone; Other: Observation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
• Actual Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: May 31, 2010
• Actual Study Completion Date: May 31, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pioglitazone 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg	Drug: Pioglitazone; Participants will take oral Pioglitazone 45 mg daily for 16 weeks.; Other Names: Actos
Sham Comparator: Observation/Comparison 10 male patients with lipodystrophy not taking daily Pioglitazone	Other: Observation; Participants will be observed for 16 weeks but will not receive drug; Other Names: Comparison

Outcome Measures

Primary Outcome Measures

1. Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg [16 weeks]

   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

Secondary Outcome Measures

1. Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Participants must be 18 years of age or older of all racial and ethnic origins, and capable of giving informed consent. Spanish speaking individuals are eligible for participation.

Additionally they must be/have:

1. Biologically male (not transgendered)

2. HIV positive for at least 24 months,

3. On stable HAART for at least the last 3 months prior to entering the study,

4. Practitioner diagnosed lipodystrophy as defined by:

aHAL (any of these) decreased subcutaneous fat in the limbs with prominent veins, loss of buttock fat or facial atrophy hHAL: fat accumulation in abdomen and/or dorsocervical region

Exclusion Criteria:

Participants cannot be less than 18 years of age, institutionalized, nor have prior diseases or conditions that may alter body fat composition. Exclusions:

1. Females are excluded

2. Prior history of CHF

3. Prior history of macular retinal edema

4. Prior history of spontaneous bone fracture

5. Diabetics receiving oral/injected/inhaled diabetic agents or individuals with a fasting blood glucose value greater than or equal to 140 within the last 90 days.

6. Current active opportunistic infections for example :

7. PCP pneumonia

8. Neuropathy

9. Thrush

10. Systemic KS (Kaposi sarcoma)

1. localized cutaneous lesions are not an exclusion e) MAC (Mycobacterium Avium complex) f) Histoplasmosis g) Coccidioidomycosis

1. Planning to discontinue HAART

2. Current diagnosis of cancer or receiving chemotherapy

3. Systemic steroid use during the prior 6 months

4. Hepatitis C+ or previous diagnosis of cirrhosis

5. Liver Function Studies great than or equal to triple of normal values

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390-9173

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• Takeda Pharmaceuticals North America, Inc.

Investigators

• Principal Investigator: Nancy Rollins, MD, UT Southwestern Medical Center at Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01023620
• Other Study ID Numbers: Takeda IISR - MSA-PIO-028
• First Posted: Dec 2, 2009
• Last Update Posted: Oct 8, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by University of Texas Southwestern Medical Center: HIV; Lipodystrophy; Lipoatrophy; Lipohypertrophy; Human Immunodeficiency Virus
• Additional relevant MeSH terms: Lipodystrophy; Pioglitazone

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Pioglitazone	Observation/Comparison	Total
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 Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []
0 Participants () []

Outcome Measures

1. Primary Outcome

Title	Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
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

Outcome Measure Data

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
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
Measure Participants	0	0

2. Secondary Outcome

Title	Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Investigator left the university mid way through the study and unable to find him.

Arm/Group Title	Pioglitazone	Observation/Comparison
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
Measure Participants	0	0

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pioglitazone		Observation/Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Pioglitazone		Observation/Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.