Trial Outcomes & Findings for Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (NCT NCT01077960)
NCT ID: NCT01077960
Last Updated: 2013-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
126 participants
Primary outcome timeframe
baseline to 12 weeks
Results posted on
2013-08-07
Participant Flow
Study Initiation Date: 03 Feb 2005 (date of first subject, first dose) Study Completion Date 04 Jan 2006 (date of last subject, last visit) 26 study centers in the United States and British Columbia participated in this study, with each center enrolling at least one subject into the study.
Any subject who was enrolled in Serono Study 24380, assigned to Group A, and fully completed all study visits without major protocol violations was to be allowed to enroll in Study 25373
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
126
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Subject decision
|
1
|
|
Overall Study
Reason unspecified
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Baseline characteristics by cohort
| Measure |
Serostim
n=126 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
45.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
|
Insulin-like Growth Factor I
|
242.6 ng/mL
STANDARD_DEVIATION 132.8 • n=5 Participants
|
|
Oral Glucose Tolerance Testing - 120 Minute Glucose
|
102.3 mg/dL
STANDARD_DEVIATION 35.7 • n=5 Participants
|
|
Oral Glucose Tolerance Testing - Fasting Glucose
|
94.5 mg/dL
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Oral Glucose Tolerance Testing - Fasting Insulin
|
11.4 mcIU/mL
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Trunk Fat
|
10.4 kg
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Waist Circumference
|
97.3 cm
STANDARD_DEVIATION 9.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: The analysis population reported here comprised the subjects who received at least one dose of study drug
Outcome measures
| Measure |
Serostim
n=106 Participants
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)
|
|---|---|
|
Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
|
-1.7 kg
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: The analysis population reported here comprised the subjects who received at least one dose of study drug
Measured by anthropometry
Outcome measures
| Measure |
Serostim
n=116 Participants
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)
|
|---|---|
|
Change From Baseline to Week 12 in Waist Circumference
|
-1.5 cm
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: The analysis population reported here comprised the subjects who received at least one dose of study drug
Circulating levels of IGF-I
Outcome measures
| Measure |
Serostim
n=112 Participants
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)
|
|---|---|
|
Change From Baseline to Week 12 in Insulin-like Growth Factor I
|
135.7 ng/mL
Standard Deviation 210.7
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: The analysis population reported here comprised the subjects who received at least one dose of study drug
Oral glucose tolerance testing
Outcome measures
| Measure |
Serostim
n=111 Participants
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)
|
|---|---|
|
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin
|
10.8 mcIU/mL
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: The analysis population reported here comprised the subjects who received at least one dose of study drug
Oral glucose testing
Outcome measures
| Measure |
Serostim
n=105 Participants
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)
|
|---|---|
|
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose
|
11.7 mg/dL
Standard Deviation 43.7
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: The analysis population reported here comprised the subjects who received at least one dose of study drug
Oral glucose testing
Outcome measures
| Measure |
Serostim
n=124 Participants
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)
|
|---|---|
|
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose
|
4.5 mg/dL
Standard Deviation 20.4
|
Adverse Events
Serostim
Serious events: 2 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Serostim
n=126 participants at risk
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)
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.79%
1/126 • Number of events 1 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Infections and infestations
Diverticulitis
|
0.79%
1/126 • Number of events 1 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
Other adverse events
| Measure |
Serostim
n=126 participants at risk
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)
|
|---|---|
|
General disorders
Oedema peripheral
|
24.6%
31/126 • Number of events 47 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
21/126 • Number of events 30 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
9/126 • Number of events 9 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Investigations
Blood glucose increased
|
6.3%
8/126 • Number of events 8 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.3%
8/126 • Number of events 11 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
8/126 • Number of events 10 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
8/126 • Number of events 9 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
7/126 • Number of events 7 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Psychiatric disorders
Insomnia
|
5.6%
7/126 • Number of events 7 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
7/126 • Number of events 10 • Adverse events were to be reported and collected on an ongoing basis from the day of written informed consent (baseline) until 4 weeks after the last investigational product administration.
Adverse events occurring during study treatment are reported
|
Additional Information
EMD Serono Medical Information
EMD Serono
Phone: 1-888-ASK-SERO (275-7376)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER