Therapeutic Approaches to HAART-Induced Lipodystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00461552
• Date of registration: 16/04/2007
• Prospective Registration: No
• Primary sponsor: University of Texas Southwestern Medical Center
• Public title: Therapeutic Approaches to HAART-Induced Lipodystrophy
• Scientific title: Therapeutic Approaches to HAART-Induced Lipodystrophy
• Date of first enrolment: January 2003
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00461552
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Abhimanyu Garg, M.D.
• Affiliation: Univeristy of Texas Southwestern Medical Center

Key inclusion & exclusion 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



Age minimum: 14 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Lipodystrophy

Intervention(s)

Drug: Leptin

Other: Placebo

Primary Outcome(s)

Fasting Serum Triglycerides [Time Frame: 6 months]

Secondary Outcome(s)

Body Weight (kg) [Time Frame: 6 months]

Secondary ID(s)

063656

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amylin Pharmaceuticals, LLC.

Results

• Results available: Yes
• Date Posted: 05/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00461552