Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
| Group | Value (kg) | Spread |
|---|---|---|
| Serostim | -1.7 | 1.4 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Canada
1 trial · 1 completed · 1 with posted results
Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
NCT01077960Feb 2005 to Jan 2006
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007). In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.
Experimental
Serostim
Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment \[Serono Study 24380\] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
Outcomes the sponsor listed as primary.
Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
Time frame · baseline to 12 weeks
Change From Baseline to Week 12 in Waist Circumference
Time frame · baseline to 12 weeks
Measured by anthropometry
Change From Baseline to Week 12 in Insulin-like Growth Factor I
Time frame · baseline to 12 weeks
Circulating levels of IGF-I
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin
Time frame · baseline to 12 weeks
Oral glucose tolerance testing
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose
Time frame · baseline to 12 weeks
Oral glucose testing
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose
Time frame · baseline to 12 weeks
Oral glucose testing
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (kg) | Spread |
|---|---|---|
| Serostim | -1.7 | 1.4 |
| Group | Value (cm) | Spread |
|---|---|---|
| Serostim | -1.5 | 3.0 |
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Serostim | 135.7 | 210.7 |
| Group | Value (mcIU/mL) | Spread |
|---|---|---|
| Serostim | 10.8 | 22.3 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Serostim | 11.7 | 43.7 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Serostim | 4.5 | 20.4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SerostimSerostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment \[Serono Study 24380\] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day) | – | 2 / 126 | 89 / 126 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2007
Grunfeld et al. 2007Journal of acquired immune deficiency syndromes (1999)cited by 34
PMID 17592343DOI 10.1097/qai.0b013e3180691145PUB-17592343
Who could join, as posted.
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