Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00140244
• Date of registration: 30/08/2005
• Prospective Registration: No
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
• Scientific title: Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
• Date of first enrolment: December 2001
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00140244
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years old

- Documented HIV infection

- Exposed to at least 6 months of cumulative highly active antiretroviral medications
for HIV

- Developed fat depletion after starting HIV medications

- Low leptin level in the blood

- Fasting triglyceride level > 300 mg/dl

Exclusion Criteria:

- Active infectious diseases, except HIV

- Diabetes prior to starting HIV medications

- Alcohol or drug abuse

- Triglyceride level > 1000 mg/dl

- Significant kidney, liver, or thyroid dysfunction

- Cancer or lymphoma

- Pregnancy or planning to become pregnant during the study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HAART-induced Lipodystrophy and Metabolic Syndrome

Intervention(s)

Drug: Placebo

Drug: r-metHuLeptin

Primary Outcome(s)

Serum Lipid Levels [Time Frame: At the end of each two month intervention]

Secondary Outcome(s)

CD4+ Lymphocytes [Time Frame: At the end of each two month intervention]

Free Fatty Acid (FFA) Levels [Time Frame: At the end of each two month intervention]

Fibrinogen [Time Frame: At the end of each two month intervention]

Viral Load [Time Frame: At the end of each two month intervention]

Interleukin-6 (IL-6) Levels [Time Frame: At the end of each two month intervention]

Hepatic Fat Content [Time Frame: At the end of each two month intervention]

Low Density Lipoprotein (LDL) Cholesterol Levels [Time Frame: At the end of each two month intervention]

Insulin Resistance (as Assessed by HOMA-IR) [Time Frame: At the end of each two month intervention]

Blood Pressure [Time Frame: At the end of each two month intervention]

Glycemia (as Assessed by Fasting Glucose) [Time Frame: At the end of each two month intervention]

Insulin Levels [Time Frame: At the end of each two month intervention]

Lean Body Mass [Time Frame: At the end of each two month intervention]

Secondary ID(s)

R01DK058785

2001P000484

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Amgen

Results

• Results available: Yes
• Date Posted: 06/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00140244