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
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ClinicalTrials.gov Identifier: NCT00294918 |
Recruitment Status
:
Completed
First Posted
: February 22, 2006
Last Update Posted
: March 26, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) Human Immunodeficiency Virus Infections | Drug: Serostim® | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 142 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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) |
Study Start Date : | September 2001 |
Actual Primary Completion Date : | February 2003 |
Actual Study Completion Date : | February 2003 |

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 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)
|
- 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 ]
- 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 ]
- Change from Week 12 in weight measured on a calibrated scale at Week 36 [ Time Frame: Week 12 and Week 36 ]
- Change from Week 12 in total body fat quantified by DXA at Week 36 [ Time Frame: Week 12 and Week 36 ]
- Change from Week 12 in lean body mass quantified by DXA at Week 36 [ Time Frame: Week 12 and Week 36 ]
- Change from Week 12 in maximal chest, waist, and hip circumference at Week 36 [ Time Frame: Week 12 and Week 36 ]
- Change from Week 12 in waist/hip ratio at Week 36 [ Time Frame: Week 12 and Week 36 ]
- Change from Week 12 in Dorsocervical Fat Pad at Week 36 [ Time Frame: Week 12 and Week 36 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294918
Study Director: | Norma Muurahainen, M.D. PhD | EMD Serono |
Additional Information:
Publications:
Responsible Party: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00294918 History of Changes |
Other Study ID Numbers: |
23056 |
First Posted: | February 22, 2006 Key Record Dates |
Last Update Posted: | March 26, 2014 |
Last Verified: | March 2014 |
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 |