Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01023620 |
| Primary Contact: |
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Principal Investigator
Michael Limerick, RN, PhD
UT Southwestern Medical Center at Dallas
Michael Limerick, RN, PhD
Phone: 214-590-8557
Email: Michael.Limerick@utsouthwestern.edu
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| Backup Contact: |
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Email: Minerva.Santos@UTSouthwestern.edu
Minerva Santos
Phone: 214-590-2794
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| Location Contact: |
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Dallas, Texas 75390
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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