HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT01023620 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pioglitazone (Drug); Observation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg |
— | — |
| SECONDARY Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg |
— | — |
Summary
Eligibility 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:
- Biologically male (not transgendered)
- HIV positive for at least 24 months,
- On stable HAART for at least the last 3 months prior to entering the study,
- 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:
- Females are excluded
- Prior history of CHF
- Prior history of macular retinal edema
- Prior history of spontaneous bone fracture
- 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.
- Current active opportunistic infections for example :
- PCP pneumonia
- Neuropathy
- Thrush
- Systemic KS (Kaposi sarcoma)
i) localized cutaneous lesions are not an exclusion e) MAC (Mycobacterium Avium complex) f) Histoplasmosis g) Coccidioidomycosis
- Planning to discontinue HAART
- Current diagnosis of cancer or receiving chemotherapy
- Systemic steroid use during the prior 6 months
- Hepatitis C+ or previous diagnosis of cirrhosis
- Liver Function Studies great than or equal to triple of normal values
Data sourced from ClinicalTrials.gov (NCT01023620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.