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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections	Drug: Serostim®	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	142 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	September 2001
Actual Primary Completion Date :	February 2003
Actual Study Completion Date :	February 2003

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Serostim® (1 mg)	Drug: Serostim®; 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.; Other Name: recombinant human growth hormone (r-hGH)
Experimental: Serostim® (2 mg)	Drug: Serostim®; 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.; Other Name: recombinant human growth hormone (r-hGH)
Experimental: Serostim® (4 mg)	Drug: Serostim®; 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.; Other Name: recombinant human growth hormone (r-hGH)

Outcome Measures

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Primary Outcome Measures :

1. 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 Measures :

1. 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 ]
2. Change from Week 12 in weight measured on a calibrated scale at Week 36 [ Time Frame: Week 12 and Week 36 ]
3. Change from Week 12 in total body fat quantified by DXA at Week 36 [ Time Frame: Week 12 and Week 36 ]
4. Change from Week 12 in lean body mass quantified by DXA at Week 36 [ Time Frame: Week 12 and Week 36 ]
5. Change from Week 12 in maximal chest, waist, and hip circumference at Week 36 [ Time Frame: Week 12 and Week 36 ]
6. Change from Week 12 in waist/hip ratio at Week 36 [ Time Frame: Week 12 and Week 36 ]
7. Change from Week 12 in Dorsocervical Fat Pad at Week 36 [ Time Frame: Week 12 and Week 36 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:	Norma Muurahainen, M.D. PhD	EMD Serono

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Full FDA approved prescribing information can be found here 

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.

Responsible Party:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00294918 History of Changes
Other Study ID Numbers:	23056
First Posted:	February 22, 2006
Last Update Posted:	March 26, 2014
Last Verified:	March 2014

Keywords provided by EMD Serono:

Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections; Serostim®; recombinant human growth hormone (r-hGH)

Additional relevant MeSH terms:

Syndrome; Virus Diseases; Immunologic Deficiency Syndromes; Acquired Immunodeficiency Syndrome; HIV Infections; Disease; Pathologic Processes; Immune System Diseases; Lentivirus Infections	Retroviridae Infections; RNA Virus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs