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 range14 Years – 65 Years
SexALL
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…
What they're measuring
1
Fasting Serum Triglycerides
Timeframe: 6 months
Trial details
NCT IDNCT00461552
SponsorUniversity of Texas Southwestern Medical Center