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

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: HAART-induced Lipodystrophy and Metabolic Syndrome

Treatments: Drug: Placebo; Drug: r-metHuLeptin

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00140244

R01DK058785 (U.S. NIH Grant/Contract)

2001P000484

Details and patient eligibility

About

The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.

Full description

Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV+ patients. The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy.

Comparison: Leptin-treated group to placebo-treated group

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

7 participants in 2 patient groups, including a placebo group

r-MetHuLeptin

Active Comparator group

Description:

r-MetHuLeptin SubQ once daily

Treatment:

Drug: r-metHuLeptin

Placebo

Placebo Comparator group

Description:

SubQ once daily

Treatment:

Drug: Placebo