HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedion… (NCT01023620) | Clinical Trial Compass
CompletedNot Applicable
HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
United States4 participantsStarted 2009-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Exclusion criteria
. Females are excluded
. Prior history of CHF
. Prior history of macular retinal edema
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
Timeframe: 16 weeks
Trial details
NCT IDNCT01023620
SponsorUniversity of Texas Southwestern Medical Center
. 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 :