Phase 2 N=7 Randomized Triple-blind Treatment

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

HAART-induced Lipodystrophy and Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00140244 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Serum Lipid Levels — 228.8; 219.7; 113.0; 105.7 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: r-metHuLeptin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Lipid Levels	228.8; 219.7; 113.0; 105.7; 409.0; 520.5	—
SECONDARY Insulin Resistance (as Assessed by HOMA-IR)	2.52; 4.56	—
SECONDARY Glycemia (as Assessed by Fasting Glucose)	91; 95.6	—
SECONDARY Low Density Lipoprotein (LDL) Cholesterol Levels	113; 105.7	—
SECONDARY Free Fatty Acid (FFA) Levels	0.45; 0.61	—
SECONDARY Blood Pressure	3.2; -6.7	—
SECONDARY Fibrinogen	252.2; 294.4	—
SECONDARY Insulin Levels	11.6; 20.3	—
SECONDARY Lean Body Mass	58.6; 61.6	—
SECONDARY Viral Load	11345; 12367	—
SECONDARY CD4+ Lymphocytes	556.6; 637.2	—
SECONDARY Interleukin-6 (IL-6) Levels	1.65; 2.14	—
SECONDARY Hepatic Fat Content	4.02; 4.01	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00140244). 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.