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
Information source: EMD Serono
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections
Intervention: Serostim® (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: EMD Serono Official(s) and/or principal investigator(s): Norma Muurahainen, M.D. PhD, Study Director, Affiliation: EMD Serono
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percent change from Week 12 in trunk fat quantified by Dual-energy X-ray absorptiometry (DXA) at Week 36
Secondary outcome: Change from Week 12 in ratio of trunk fat to limb fat quantified by DXA at Week 36Change 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Full FDA approved prescribing information can be found here
Related publications: 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.
Starting date: September 2001
Last updated: March 24, 2014
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