Clinical trial NCT01023620: HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
Official title: Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Lipodystrophy
Lipoatrophy
Lipohypertrophy
Human Immunodeficiency Virus
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2009-12-02
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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:

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

Primary outcomes:
measure: Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
timeFrame: 16 weeks
Secondary outcomes:
measure: Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Nancy Rollins, MD
role: PRINCIPAL_INVESTIGATOR
References: