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 - Full Text View

Purpose

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	Intervention	Phase
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) Human Immunodeficiency Virus Infections	Drug: Serostim®	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hormones

Drug Information available for: Somatropin

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Change from Week 12 in weight measured on a calibrated scale at Week 36 [ Time Frame: Week 12 and Week 36 ] [ Designated as safety issue: No ]
Change from Week 12 in total body fat quantified by DXA at Week 36 [ Time Frame: Week 12 and Week 36 ] [ Designated as safety issue: No ]
Change from Week 12 in lean body mass quantified by DXA at Week 36 [ Time Frame: Week 12 and Week 36 ] [ Designated as safety issue: No ]
Change from Week 12 in maximal chest, waist, and hip circumference at Week 36 [ Time Frame: Week 12 and Week 36 ] [ Designated as safety issue: No ]
Change from Week 12 in waist/hip ratio at Week 36 [ Time Frame: Week 12 and Week 36 ] [ Designated as safety issue: No ]
Change from Week 12 in Dorsocervical Fat Pad at Week 36 [ Time Frame: Week 12 and Week 36 ] [ Designated as safety issue: No ]


Enrollment:	142
Study Start Date:	September 2001
Study Completion Date:	February 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294918

Sponsors and Collaborators

EMD Serono

Investigators


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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

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
Study First Received:	February 17, 2006
Last Updated:	March 24, 2014
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016