Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
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ClinicalTrials.gov Identifier: NCT00082628 |
Recruitment Status :
Completed
First Posted : May 17, 2004
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
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Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
HIV Infections Lipodystrophy |
Interventions |
Drug: Placebo Drug: Serostim® 4 mg Drug: Serostim® 2 mg |
Enrollment | 326 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Period I: Placebo | Period I: Serostim® 4 mg | Period II: Serostim® 4 mg to Placebo | Period II: Serostim® 4 mg to Serostim® 2 mg | Period II: Placebo to Placebo/Serostim® 4 mg |
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Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. | Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks. | All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II. | All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II. | All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks. |
Period Title: Treatment Period I (Week 1 to Week 12) | |||||
Started | 81 | 245 | 0 | 0 | 0 |
Completed | 73 | 185 | 0 | 0 | 0 |
Not Completed | 8 | 60 | 0 | 0 | 0 |
Reason Not Completed | |||||
Subjects Did Not Receive Study Drug | 0 | 1 | 0 | 0 | 0 |
Subjects Without Post-Baseline Assessmen | 2 | 1 | 0 | 0 | 0 |
Subjects Did Not Complete Week 12 | 5 | 43 | 0 | 0 | 0 |
Did not continue to Period II | 1 | 15 | 0 | 0 | 0 |
Period Title: Treatment Period II: Week 12 to Week 36 | |||||
Started | 0 | 0 | 93 | 92 | 73 |
Completed | 0 | 0 | 78 | 76 | 55 |
Not Completed | 0 | 0 | 15 | 16 | 18 |
Reason Not Completed | |||||
Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 |
Subjects Did Not Complete Week 36 | 0 | 0 | 15 | 15 | 17 |
Baseline Characteristics
Arm/Group Title | Period I: Placebo | Period I: Serostim® 4 mg | Total | |
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Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. | Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 79 | 243 | 322 | |
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The modified ITT Population (ITT) for Period I was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 79 participants | 243 participants | 322 participants | |
45.5 (7.5) | 44.5 (7.0) | 44.8 (7.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | 243 participants | 322 participants | |
Female |
11 13.9%
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36 14.8%
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47 14.6%
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Male |
68 86.1%
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207 85.2%
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275 85.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Merck KGaA Communication Center |
Organization: | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany |
Phone: | +49-6151-72-5200 |
EMail: | service@merckgroup.com |
Responsible Party: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00082628 |
Other Study ID Numbers: |
24380 |
First Submitted: | May 13, 2004 |
First Posted: | May 17, 2004 |
Results First Submitted: | October 2, 2017 |
Results First Posted: | July 20, 2018 |
Last Update Posted: | July 20, 2018 |