Back to resultsAn Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome
Primary Purpose
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Serostim®
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) focused on measuring Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections, Serostim®, recombinant human growth hormone (r-hGH)
Eligibility Criteria
Inclusion Criteria: Complete all treatments prescribed by the antecedent protocol (Study 22388) Be able and willing to comply with the protocol for the duration of the study, including concomitant therapy restrictions Have given written informed consent If female, be post-menopausal, surgically sterile, or using adequate contraception Exclusion Criteria: Experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study (Study 22388) Withdrew from the antecedent study or was discontinued prematurely for any other reason Based on the Final Visit evaluations from the antecedent trial, would be required to withdraw from the antecedent protocol, if (theoretically) the antecedent trial continued beyond the Final Visit Based on the Final Visit evaluations from the antecedent trial, would be required to temporarily stop or reduce the dose of study drug, if (theoretically) the antecedent trial continued beyond the Final Visit. This does not apply to subjects whose study drug was temporarily stopped or whose study drug dose was reduced prior to the Final Visit (Screening), provided they continued in the antecedent protocol and are stable at the time of the Final Visit (Screening)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Serostim® (1 mg)
Serostim® (2 mg)
Serostim® (4 mg)
Arm Description
Outcomes
Primary Outcome Measures
Percent change from Week 12 in trunk fat quantified by Dual-energy X-ray absorptiometry (DXA) at Week 36
Secondary Outcome Measures
Change from Week 12 in ratio of trunk fat to limb fat quantified by DXA at Week 36
Change from Week 12 in weight measured on a calibrated scale at Week 36
Change from Week 12 in total body fat quantified by DXA at Week 36
Change from Week 12 in lean body mass quantified by DXA at Week 36
Change from Week 12 in maximal chest, waist, and hip circumference at Week 36
Change from Week 12 in waist/hip ratio at Week 36
Change from Week 12 in Dorsocervical Fat Pad at Week 36
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00294918
Brief Title
An Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome
Official Title
Multicenter Open-label, Randomized, Dose-finding, Parallel-group, Safety and Efficacy Trial of Subcutaneous Administration of Serostim® (Mammalian Cell-derived Recombinant Human Growth Hormone, r-hGH) in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
4. Oversight
5. Study Description
Brief Summary
This is an open-label, multi-center, randomized, parallel-group, maintenance trial of Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects, who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram (mg) dose. All other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1:1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections
Keywords
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections, Serostim®, recombinant human growth hormone (r-hGH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serostim® (1 mg)
Arm Type
Experimental
Arm Title
Serostim® (2 mg)
Arm Type
Experimental
Arm Title
Serostim® (4 mg)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Serostim®
Other Intervention Name(s)
recombinant human growth hormone (r-hGH)
Intervention Description
Serostim® will be administered subcutaneously at a dose of 1 mg to subjects who had encountered toxicity during the antecedent protocol (Study 22388) whereas, other subjects will be randomized in 1:1 ratio, to receive either 2 milligram (mg) or 4 mg (on a weight adjusted basis) daily, starting from Day 1 of Week 1 up to Week 12 (Period 1). During Period 1, subjects who encounter toxicity will receive 1 mg Serostim® subcutaneously, daily for Period 2, starting from Day 1 of Week 13, whereas other subjects will be randomized in a 1:1 ratio to receive either 2 mg or 1 mg (on a weight adjusted basis) up to Week 36.
Primary Outcome Measure Information:
Title
Percent change from Week 12 in trunk fat quantified by Dual-energy X-ray absorptiometry (DXA) at Week 36
Time Frame
Week 12 and Week 36
Secondary Outcome Measure Information:
Title
Change from Week 12 in ratio of trunk fat to limb fat quantified by DXA at Week 36
Time Frame
Week 12 and Week 36
Title
Change from Week 12 in weight measured on a calibrated scale at Week 36
Time Frame
Week 12 and Week 36
Title
Change from Week 12 in total body fat quantified by DXA at Week 36
Time Frame
Week 12 and Week 36
Title
Change from Week 12 in lean body mass quantified by DXA at Week 36
Time Frame
Week 12 and Week 36
Title
Change from Week 12 in maximal chest, waist, and hip circumference at Week 36
Time Frame
Week 12 and Week 36
Title
Change from Week 12 in waist/hip ratio at Week 36
Time Frame
Week 12 and Week 36
Title
Change from Week 12 in Dorsocervical Fat Pad at Week 36
Time Frame
Week 12 and Week 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Complete all treatments prescribed by the antecedent protocol (Study 22388)
Be able and willing to comply with the protocol for the duration of the study, including concomitant therapy restrictions
Have given written informed consent
If female, be post-menopausal, surgically sterile, or using adequate contraception
Exclusion Criteria:
Experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study (Study 22388)
Withdrew from the antecedent study or was discontinued prematurely for any other reason
Based on the Final Visit evaluations from the antecedent trial, would be required to withdraw from the antecedent protocol, if (theoretically) the antecedent trial continued beyond the Final Visit
Based on the Final Visit evaluations from the antecedent trial, would be required to temporarily stop or reduce the dose of study drug, if (theoretically) the antecedent trial continued beyond the Final Visit. This does not apply to subjects whose study drug was temporarily stopped or whose study drug dose was reduced prior to the Final Visit (Screening), provided they continued in the antecedent protocol and are stable at the time of the Final Visit (Screening)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Muurahainen, M.D. PhD
Organizational Affiliation
EMD Serono
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
Citation
Low-dose Maintenance Therapy with Recombinant Human Growth Hormone Sustains Effects of Previous r-hGH Treatment in HIV+ Patients with Excess Center Fat: Treatment Results at 60 Weeks D P Kotler, C Grunfeld, N Muurahainen, C Wanke, M Thompson, D Bock, J Gertner, and Serostim in the Treatment of Adipose Redistribution Syndrome (STARS) Trial Investigator Group. Abstract. 11th Conference on Retroviruses and Opportunistic Infections. February 8-11, 2004, Moscone West, San Francisco CA, USA.
Results Reference
background
Links:
URL
http://www.retroconference.org/2004/cd/Abstract/80.htm
Description
Related Info
URL
http://www.serostim.com
Description
Full FDA approved prescribing information can be found here
Learn more about this trial
An Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome
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