Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Phase III, Multi-Center, Open, 12-Week, Follow-up Safety and Efficacy Study of Serostim® in Subjects With Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
1 other identifier
interventional
126
2 countries
26
Brief Summary
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007). In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2005
Shorter than P25 for phase_3
26 active sites
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
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedResults Posted
Study results publicly available
June 23, 2010
CompletedAugust 7, 2013
August 1, 2013
11 months
February 26, 2010
May 25, 2010
August 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
baseline to 12 weeks
Secondary Outcomes (5)
Change From Baseline to Week 12 in Waist Circumference
baseline to 12 weeks
Change From Baseline to Week 12 in Insulin-like Growth Factor I
baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin
baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose
baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose
baseline to 12 weeks
Study Arms (1)
Serostim
EXPERIMENTALSerostim® 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)
Interventions
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)
Eligibility Criteria
You may not qualify if:
- Must be taking antiretroviral medications that are approved or are available under a Treatment Investigational New Drug (IND). Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
- Must be willing and able to comply with the protocol for the duration of the study.
- Must have voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act of 1996 (HIPAA), prior to any study-related procedure that is not part of normal medical care, and with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
- If female, subjects must either:
- Be post menopausal (=/\>1 year) or surgically sterilized (i.e., have undergone tubal ligation or hysterectomy), or
- Use a contraceptive method for the duration of the study such as: hormonal contraceptive,intra uterine device,diaphragm with spermicide, or condom with spermicide, and
- Must be neither pregnant nor breast feeding.
- Confirmation that female subjects of childbearing potential are not pregnant must be established by a negative pregnancy test prior to initiating first treatment.
- A pregnancy test is not required if the subject is post menopausal or surgically sterilized.
- Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
- Have any active malignancy, except localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy).
- Have active central nervous system (CNS) process associated with neurological findings.
- Have acute illness treated in an intensive care unit, e.g., due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
- Have any medical condition in view of which the study doctor and/or Serono Medical/Therapeutic Director feels that it would be in the best interest of the subject not to participate in the follow-up study.
- Are unable to comply with the Concomitant Therapy restrictions as outlined in Section 5.5 and listed as follows:
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (26)
University of Alabama/Birmingham
Birmingham, Alabama, United States
Care Clinic
Los Angeles, California, United States
Private Practice
Palm Beach, California, United States
UCSD - AVRC (AntiViralResearchCenter)
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Harbor-UCLA Medical Center
Torrence, California, United States
AIDS Alliance
West Hollywood, California, United States
Circle Medical LLC
Norwalk, Connecticut, United States
Private Practice
Washington D.C., District of Columbia, United States
Private Practice
Fort Lauderdale, Florida, United States
Care Resources
Miami, Florida, United States
Private Practice
Miami, Florida, United States
Private Practice
North Miami Beach, Florida, United States
Infectious Disease Associates
Sarasota, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
St. Luke's Roosevelt Hospital
New York, New York, United States
St. Vincents Catholic Medical Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Central Texas Clinical Research
Austin, Texas, United States
IPD Research
Annandale, Virginia, United States
Private Practice
Spokane, Washington, United States
St Paul Hospital
Vancouver, British Columbia, Canada
Related Publications (1)
Grunfeld C, Thompson M, Brown SJ, Richmond G, Lee D, Muurahainen N, Kotler DP; Study 24380 Investigators Group. Recombinant human growth hormone to treat HIV-associated adipose redistribution syndrome: 12 week induction and 24-week maintenance therapy. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):286-97. doi: 10.1097/QAI.0b013e3180691145.
PMID: 17592343BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- EMD Serono Medical Information
- Organization
- EMD Serono
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
March 1, 2010
Study Start
February 1, 2005
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
August 7, 2013
Results First Posted
June 23, 2010
Record last verified: 2013-08