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Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ashok Balasubramanyam, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01511016
First received: January 11, 2012
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Lipodystrophy
Interventions: Drug: Human recombinant leptin ("metreleptin")
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV-positive subjects meeting the entry criteria were recruited from March, 2003 until November, 2010 from the clinics of Harris County Hospital District, and Legacy Community Health Center, Houston.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If a potential study subject was already taking a lipid lowering medication at the time of screening but was otherwise eligible for the study, he/she was invited to stop the medication for 6 weeks, at the end of which the fasting triglyceride level was re-measured to gauge eligibility.

Reporting Groups
  Description
Placebo Injection

Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Human Recombinant Leptin (Metreleptin)

Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.


Participant Flow:   Overall Study
    Placebo Injection   Human Recombinant Leptin (Metreleptin)
STARTED   8   9 
COMPLETED   6   7 
NOT COMPLETED   2   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Injection

Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Human Recombinant Leptin (Metreleptin)

Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Total Total of all reporting groups

Baseline Measures
   Placebo Injection   Human Recombinant Leptin (Metreleptin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   17 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   8   9   17 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.1  (6.8)   44.9  (7.8)   46.9  (7.3) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   8   9   17 
Region of Enrollment 
[Units: Participants]
     
United States   8   9   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Total Lipolysis   [ Time Frame: 4 months after treatment ]

2.  Primary:   Rate of Net Lipolysis   [ Time Frame: 4 months after treatment ]

3.  Secondary:   Rates of Fatty Acid Oxidation   [ Time Frame: 4 months after treatment ]

4.  Secondary:   Fasting Plasma Non-HDL-C   [ Time Frame: 4 months after treatment. ]

5.  Secondary:   Glucose Levels After Glucose Challenge   [ Time Frame: 4 months after treatment. ]

6.  Secondary:   Insulin Levels After Oral Glucose Challenge.   [ Time Frame: 4 months after treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Relatively small sample size.
  2. Early drop-out of 3 subjects (2 in placebo arm, 2 in metreleptin arm).
  3. Possible confounders in phenotypic hetereogeneity of HIV lipodystrophy, and differences in antiretroviral drugs.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Leanne Scott, PhD, Director of Sponsored Programs
Organization: Baylor College of Medicine
phone: 713-798-6978
e-mail: lbscott@bcm.edu


Publications of Results:

Responsible Party: Ashok Balasubramanyam, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01511016     History of Changes
Other Study ID Numbers: H-13372
Study First Received: January 11, 2012
Results First Received: August 13, 2013
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration