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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01023620
• Date of registration: 30/11/2009
• Prospective Registration: No
• Primary sponsor: University of Texas Southwestern Medical Center
• Public title: HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) HAL
• Scientific title: Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
• Date of first enrolment: October 2009
• Target sample size: 4
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01023620
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Nancy Rollins, MD
• Affiliation: UT Southwestern Medical Center at Dallas

Key inclusion & exclusion criteria

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 :

1. PCP pneumonia

2. Neuropathy

3. Thrush

4. Systemic KS (Kaposi sarcoma)

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

7. Planning to discontinue HAART

8. Current diagnosis of cancer or receiving chemotherapy

9. Systemic steroid use during the prior 6 months

10. Hepatitis C+ or previous diagnosis of cirrhosis

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Other: Observation

Drug: Pioglitazone

Primary Outcome(s)

Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg [Time Frame: 16 weeks]

Secondary Outcome(s)

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

Secondary ID(s)

Takeda IISR - MSA-PIO-028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Pharmaceuticals North America, Inc.

Results

• Results available: Yes
• Date Posted: 08/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01023620