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

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)

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus Infections; Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
• Intervention / Treatment: Drug: Serostim®

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: recombinant human growth hormone (r-hGH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from Week 12 in trunk fat quantified by Dual-energy X-ray absorptiometry (DXA) at Week 36	Week 12 and Week 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Week 12 in ratio of trunk fat to limb fat quantified by DXA at Week 36	Week 12 and Week 36
Change from Week 12 in weight measured on a calibrated scale at Week 36	Week 12 and Week 36
Change from Week 12 in total body fat quantified by DXA at Week 36	Week 12 and Week 36
Change from Week 12 in lean body mass quantified by DXA at Week 36	Week 12 and Week 36
Change from Week 12 in maximal chest, waist, and hip circumference at Week 36	Week 12 and Week 36
Change from Week 12 in waist/hip ratio at Week 36	Week 12 and Week 36
Change from Week 12 in Dorsocervical Fat Pad at Week 36	Week 12 and Week 36

Collaborators and Investigators

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

Publications and helpful links

General 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.

Helpful Links

• Full FDA approved prescribing information can be found here

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): February 1, 2003
• Study Completion (Actual): February 1, 2003

Study Registration Dates

• First Submitted: February 17, 2006
• First Submitted That Met QC Criteria: February 17, 2006
• First Posted (Estimate): February 22, 2006

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Serostim®; Human Immunodeficiency Virus Infections; Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); recombinant human growth hormone (r-hGH)
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Disease; Slow Virus Diseases; HIV Infections; Syndrome; Virus Diseases; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 23056