HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
HAL
Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Oct 2009
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2010
CompletedResults Posted
Study results publicly available
October 8, 2019
CompletedOctober 8, 2019
September 1, 2019
8 months
November 30, 2009
March 8, 2019
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
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
16 weeks
Secondary Outcomes (1)
Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg
16 weeks
Study Arms (2)
Pioglitazone
EXPERIMENTAL10 male patients with lipodystrophy taking daily Pioglitazone 45 mg
Observation/Comparison
SHAM COMPARATOR10 male patients with lipodystrophy not taking daily Pioglitazone
Interventions
Participants will take oral Pioglitazone 45 mg daily for 16 weeks.
Participants will be observed for 16 weeks but will not receive drug
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9173, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Limerick
- Organization
- UT Southwestern Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Rollins, MD
UT Southwestern Medical Center at Dallas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 2, 2009
Study Start
October 1, 2009
Primary Completion
May 31, 2010
Study Completion
May 31, 2010
Last Updated
October 8, 2019
Results First Posted
October 8, 2019
Record last verified: 2019-09