Phase 2
N=14
Therapeutic Approaches to HAART-Induced Lipodystrophy
HIV Infections · Lipodystrophy
Bottom Line
View on ClinicalTrials.gov: NCT00461552 ↗Enrolled (actual)
14
Serious AEs
8.3%
Results posted
Mar 2019
Primary outcome: Primary: Fasting Serum Triglycerides — 237; 341 mg/dL — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Leptin (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Serum Triglycerides |
237; 341 | 0.84 |
| SECONDARY Body Weight (kg) |
68.6; 73.3 | 0.4 |
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.
Eligibility Criteria
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 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 hyperthyroidism. Each of the 4 treatment arms has additional specific inclusion and exclusion criteria
Data sourced from ClinicalTrials.gov (NCT00461552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.