Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01077960
First received: February 26, 2010
Last updated: August 4, 2013
Last verified: August 2013
Results First Received: May 25, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Intervention: Biological: Serostim

  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
Study Initiation Date: 03 Feb 2005 (date of first subject, first dose) Study Completion Date 04 Jan 2006 (date of last subject, last visit) 26 study centers in the United States and British Columbia participated in this study, with each center enrolling at least one subject into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Any subject who was enrolled in Serono Study 24380, assigned to Group A, and fully completed all study visits without major protocol violations was to be allowed to enroll in Study 25373

Reporting Groups
  Description
Serostim Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)

Participant Flow:   Overall Study
    Serostim  
STARTED     126 [1]
COMPLETED     110 [2]
NOT COMPLETED     16  
Adverse Event                 6  
Protocol Violation                 3  
Lost to Follow-up                 5  
Subject decision                 1  
Reason unspecified                 1  
[1] 130 subjects consented to participate, 129 enrolled in the study, and 126 received study drug
[2] Modified Intent To Treat (ITT) Population



  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
Serostim Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)

Baseline Measures
    Serostim  
Number of Participants  
[units: participants]
  126  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     126  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.4  ± 7.1  
Gender  
[units: participants]
 
Female     13  
Male     113  
Region of Enrollment  
[units: participants]
 
United States     125  
Canada     1  
Insulin-like Growth Factor I [1]
[units: ng/mL]
Mean ± Standard Deviation
  242.6  ± 132.8  
Oral Glucose Tolerance Testing - 120 Minute Glucose [2]
[units: mg/dL]
Mean ± Standard Deviation
  102.3  ± 35.7  
Oral Glucose Tolerance Testing - Fasting Glucose [3]
[units: mg/dL]
Mean ± Standard Deviation
  94.5  ± 14.7  
Oral Glucose Tolerance Testing - Fasting Insulin [4]
[units: mcIU/mL]
Mean ± Standard Deviation
  11.4  ± 13.6  
Trunk Fat [5]
[units: kg]
Mean ± Standard Deviation
  10.4  ± 4.9  
Waist Circumference [6]
[units: cm]
Mean ± Standard Deviation
  97.3  ± 9.6  
[1] n=112
[2] n=105
[3] n=124
[4] n=111
[5] n=106
[6] N=116



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan   [ Time Frame: baseline to 12 weeks ]

2.  Secondary:   Change From Baseline to Week 12 in Waist Circumference   [ Time Frame: baseline to 12 weeks ]

3.  Secondary:   Change From Baseline to Week 12 in Insulin-like Growth Factor I   [ Time Frame: baseline to 12 weeks ]

4.  Secondary:   Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin   [ Time Frame: baseline to 12 weeks ]

5.  Secondary:   Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose   [ Time Frame: baseline to 12 weeks ]

6.  Secondary:   Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose   [ Time Frame: baseline to 12 weeks ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: EMD Serono Medical Information
Organization: EMD Serono
phone: 1-888-ASK-SERO (275-7376)


Publications:

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01077960     History of Changes
Other Study ID Numbers: 25373 (NCT01077960)
Study First Received: February 26, 2010
Results First Received: May 25, 2010
Last Updated: August 4, 2013
Health Authority: United States: Food and Drug Administration