Therapeutic Approaches to HAART-Induced Lipodystrophy
Condition: HIV Infections; Lipodystrophy
MeSH terms: Lipodystrophy
Intervention: Leptin; Placebo
Intervention description: weight based, sub-cutaneous injection, twice daily; weight based, sub-cutaneous injection, twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 14 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Lipodystrophy; HIV; HAART; HIV Lipodystrophy Syndrome; Lipodystrophy syndrome; HIV-Associated Lipodystrophy; HIV-Associated Lipodystrophy Syndrome; Treatment Experienced

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 < 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 hyperthyroidism. Each of the 4
             treatment arms has additional specific inclusion and exclusion criteria