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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 36

Change 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

Page last updated: August 23, 2015

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