HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) (HAL)
Recruitment status was Recruiting
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.
|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 ]
|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)|
10 male patients with lipodystrophy taking daily Pioglitazone 45 mg
Participants will take oral Pioglitazone 45 mg daily for 16 weeks.
No Intervention: Observation/Comparison
10 male patients with lipodystrophy not taking daily Pioglitazone
Participants will be observed for 16 weeks but will not receive drug
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023620
|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|