Therapeutic Approaches to HAART-Induced Lipodystrophy (NCT00461552) | Clinical Trial Compass
CompletedPhase 2
Therapeutic Approaches to HAART-Induced Lipodystrophy
United States23 participantsStarted 2003-01
Plain-language summary
To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.
Who can participate
Age range
14 Years – 65 Years
Sex
ALL
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 - General inclusion:
* Age \> 14 years
* HIV infection being treated with HIV-1 protease inhibitors for \>6 months currently, or previous protease inhibitor therapy of at least 2 years duration with development of lipodystrophy and current stable therapy preferably for past 4 months.
* Fasting serum triglycerides \> 200 mg/dL
Exclusion Criteria - General exclusion:
* Acute, ongoing AIDS-defining opportunistic infections.
* Blood CD4 positive lymphocyte count \< 200/mm3
* Known liver disease due to causes other than nonalcoholic steatohepatitis with elevation of liver transaminases by more than two and a half times above the upper limits of normal (SGOT\>105 U/L, SGPT\>120 U/L) or total bilirubin (\>1.5 mg/dL).
* Hematocrit of less than 30%.
* Current alcohol abuse (\>7 drinks or 210 g per wk for women and \>14 drinks or 420 g per wk for men).
* Current substance abuse.
* Uncontrolled diabetes mellitus with fasting plasma glucose \> 180 mg/dL or hemoglobin A1c \> 9%.
* History of weight loss during the last 3 months.
* Use of anorexiogenic drugs, thiazolidinediones, anabolic steroids and human growth hormone.
* Major Neuro-psychiatric illnesses impeding competence or compliance.
* Pregnant and lactating women.
* Cancer excluding skin cancer other than melanoma.
* Acute medical illnesses precluding participation in the studies.
* Chronic renal insufficiency with serum creatinine \> 2 mg/dL.
* Untreated thyroid disorders such as hypothyroidism and hyperthyr…
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
Fasting Serum Triglycerides
Timeframe: 6 months
Trial details
NCT IDNCT00461552
SponsorUniversity of Texas Southwestern Medical Center