HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
Recruitment status was Recruiting
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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 | Intervention |
---|---|
HIV Infections |
Drug: Pioglitazone Other: Observation |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
Official Title: | Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations |
- Percent of liver fat pre/post challenge with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Fine needle aspiration of fat pre/post with daily Pioglitazone 45 mg [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: | 24 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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.
|
No Intervention: 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
|
![](https://webarchive.library.unt.edu/web/20130309095538im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders 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:
- 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
![](https://webarchive.library.unt.edu/web/20130309095538im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Michael Limerick, RN, PhD | 214-590-8557 | Michael.Limerick@utsouthwestern.edu |
Contact: Minerva Santos | 214-590-2794 | Minerva.Santos@UTSouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center at Dallas | Recruiting |
Dallas, Texas, United States, 75390-9173 | |
Sub-Investigator: Philipp Scherer, PhD | |
Sub-Investigator: Gary Sinclair, MD | |
Sub-Investigator: Mamta K Jain, MD | |
Sub-Investigator: Jeffrey Browning, MD | |
Sub-Investigator: Maria Ramos-Ramon, MD |
Principal Investigator: | Michael Limerick, RN, PhD | UT Southwestern Medical Center at Dallas |
![](https://webarchive.library.unt.edu/web/20130309095538im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Michael Limerick, RN, PhD Assistant Professor, Internal Medicine, Infectious Diseases, UT Southwestern Medical Center at Dallas |
ClinicalTrials.gov Identifier: | NCT01023620 History of Changes |
Other Study ID Numbers: | Takeda IISR - MSA-PIO-028 |
Study First Received: | November 30, 2009 |
Last Updated: | December 1, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Texas Southwestern Medical Center:
HIV Lipodystrophy Lipoatrophy Lipohypertrophy Human Immunodeficiency Virus |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Pioglitazone 2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 07, 2013