NCT00140244

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

April 6, 2017

Completed
Last Updated

May 11, 2017

Status Verified

April 1, 2017

Enrollment Period

9.5 years

First QC Date

August 30, 2005

Results QC Date

December 22, 2015

Last Update Submit

April 6, 2017

Conditions

HAART-induced Lipodystrophy and Metabolic Syndrome

Keywords

leptinlipodystrophyinsulin resistancehyperlipidemiametabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Serum Lipid Levels

    At the end of each two month intervention

Secondary Outcomes (12)

  • Insulin Resistance (as Assessed by HOMA-IR)

    At the end of each two month intervention

  • Glycemia (as Assessed by Fasting Glucose)

    At the end of each two month intervention

  • Low Density Lipoprotein (LDL) Cholesterol Levels

    At the end of each two month intervention

  • Free Fatty Acid (FFA) Levels

    At the end of each two month intervention

  • Blood Pressure

    At the end of each two month intervention

  • +7 more secondary outcomes

Study Arms (2)

r-MetHuLeptin

ACTIVE COMPARATOR

r-MetHuLeptin SubQ once daily

Drug: r-metHuLeptin

Placebo

PLACEBO COMPARATOR

SubQ once daily

Drug: Placebo

Interventions

r-metHuLeptinDRUG
r-MetHuLeptin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9.

    PMID: 35820631DERIVED

  • Magkos F, Brennan A, Sweeney L, Kang ES, Doweiko J, Karchmer AW, Mantzoros CS. Leptin replacement improves postprandial glycemia and insulin sensitivity in human immunodeficiency virus-infected lipoatrophic men treated with pioglitazone: a pilot study. Metabolism. 2011 Jul;60(7):1045-9. doi: 10.1016/j.metabol.2010.10.002. Epub 2010 Nov 16.

    PMID: 21081243DERIVED

Related Links

MeSH Terms

Conditions

Metabolic SyndromeLipodystrophyInsulin ResistanceHyperlipidemias

Interventions

recombinant methionyl human leptin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersDyslipidemias

Results Point of Contact

Title
Dr. Christos Mantzoros
Organization
BIDMC
cmantzor@bidmc.harvard.edu
617-667-8630

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

December 1, 2001

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 11, 2017

Results First Posted

April 6, 2017

Record last verified: 2017-04

Locations

US(1)