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

EMD Serono142 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)Human Immunodeficiency Virus Infections

Interventions

Serostim®DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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