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Completed

NCT Number: NCT00294918

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: recombinant human growth hormone (r-hGH)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study 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)

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Feb 22, 2006
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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