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Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082628
Recruitment Status : Completed
First Posted : May 17, 2004
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Period I: Placebo Period I: Serostim® 4 mg Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 79 participants 243 participants 322 participants
Female
11
  13.9%
36
  14.8%
47
  14.6%
Male
68
  86.1%
207
  85.2%
275
  85.4%
1.Primary Outcome
Title Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12
Hide Description Absolute area of VAT was measured by cross-sectional computed tomography (CT) scan at the level of the L4-5 inter-vertebral disk. CT scanning was to be used to assess the cross sectional area of abdominal fat and its distribution between the visceral and subcutaneous compartments, as measured at L4-L5.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Arm/Group Title Period I: Placebo Period I: Serostim® 4 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 74 210
Mean (Standard Deviation)
Unit of Measure: Square Centimeter (cm^2)
0.5  (34.5) -32.6  (37.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Period I: Placebo, Period I: Serostim® 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Nonparametric ANCOVA Model
Comments [Not Specified]
2.Secondary Outcome
Title Treatment Period I: Change From Baseline in Trunk Fat at Week 12
Hide Description Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Arm/Group Title Period I: Placebo Period I: Serostim® 4 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 75 213
Mean (Standard Deviation)
Unit of Measure: Kilogram (Kg)
0.2  (1.3) -2.2  (1.7)
3.Secondary Outcome
Title Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12
Hide Description Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I.
Arm/Group Title Period I: Placebo Period I: Serostim® 4 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 79 243
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.23  (1.42) 0.10  (1.73)
4.Secondary Outcome
Title Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12
Hide Description Lipid profile data was analyzed for Non-HDL Cholesterol.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Arm/Group Title Period I: Placebo Period I: Serostim® 4 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 74 226
Mean (Standard Deviation)
Unit of Measure: milligram/deciliter (mg/dL)
-2.8  (28.1) -13.0  (37.1)
5.Secondary Outcome
Title Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I
Hide Description Failure rate based on VAT was assessed by CT scan at L4-L5. The failure rate was defined as the percentage of subjects who regained >50% of their VAT lost in Treatment Period I. This outcome was to be assessed for subjects who received Serostim® 4 mg in Period I.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT Population for treatment period II was defined as subjects who were re-randomized into Weeks 12 to 36 of the study and who had at least one post-Week 12 efficacy evaluation. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Arm/Group Title Period II: Serostim® 4 mg to Placebo Period II: Serostim® 4 mg to Serostim® 2 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 83 75
Measure Type: Number
Unit of Measure: percentage of subjects
53.7 40.3
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
 
Arm/Group Title Period I: Placebo (Week 1 to 12) Period I: Serostim® 4 mg (Week 1 to 12) Period II: Serostim® 4 mg to Placebo (Week 12 to 36) Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36) Period II: Placebo to Placebo (Week 12 to Week 24) Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
Hide Arm/Group Description 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 in Period II. All subjects who were initially randomized to Placebo arm in Period I and received Serostim® 4 mg daily 12 weeks in Period II.
All-Cause Mortality
Period I: Placebo (Week 1 to 12) Period I: Serostim® 4 mg (Week 1 to 12) Period II: Serostim® 4 mg to Placebo (Week 12 to 36) Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36) Period II: Placebo to Placebo (Week 12 to Week 24) Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Period I: Placebo (Week 1 to 12) Period I: Serostim® 4 mg (Week 1 to 12) Period II: Serostim® 4 mg to Placebo (Week 12 to 36) Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36) Period II: Placebo to Placebo (Week 12 to Week 24) Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/81 (2.47%)   3/244 (1.23%)   3/93 (3.23%)   2/92 (2.17%)   2/73 (2.74%)   1/73 (1.37%) 
Cardiac disorders             
Myocardial ischaemia * 2  0/81 (0.00%)  1/244 (0.41%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Cardio-respiratory arrest * 2  0/81 (0.00%)  0/244 (0.00%)  1/93 (1.08%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Gastrointestinal disorders             
Abdominal pain * 2  1/81 (1.23%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Diarrhoea * 2  0/81 (0.00%)  0/244 (0.00%)  1/93 (1.08%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Infections and infestations             
Clostridium difficile sepsis * 2  0/81 (0.00%)  0/244 (0.00%)  1/93 (1.08%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Pyelonephritis * 2  0/81 (0.00%)  0/244 (0.00%)  1/93 (1.08%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Pneumonia * 1  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  1/92 (1.09%)  0/73 (0.00%)  0/73 (0.00%) 
Diarrhoea * 2  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  1/92 (1.09%)  0/73 (0.00%)  0/73 (0.00%) 
Pancreatic insufficiency * 2  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  1/92 (1.09%)  0/73 (0.00%)  0/73 (0.00%) 
Groin abscess * 1  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  0/73 (0.00%) 
Pneumonia * 2  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  0/73 (0.00%) 
Investigations             
Liver function test abnormal * 2  0/81 (0.00%)  1/244 (0.41%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Metabolism and nutrition disorders             
Hypokalaemia * 2  0/81 (0.00%)  1/244 (0.41%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal cell carcinoma * 2  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  1/73 (1.37%) 
Nervous system disorders             
Migraine * 2  0/81 (0.00%)  1/244 (0.41%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Psychiatric disorders             
Depression * 1  1/81 (1.23%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Renal and urinary disorders             
Nephrolithiasis * 2  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  1/92 (1.09%)  0/73 (0.00%)  0/73 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pulmonary embolism * 1  0/81 (0.00%)  0/244 (0.00%)  1/93 (1.08%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Vascular disorders             
Phlebitis * 2  0/81 (0.00%)  0/244 (0.00%)  1/93 (1.08%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
2
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Period I: Placebo (Week 1 to 12) Period I: Serostim® 4 mg (Week 1 to 12) Period II: Serostim® 4 mg to Placebo (Week 12 to 36) Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36) Period II: Placebo to Placebo (Week 12 to Week 24) Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   70/81 (86.42%)   244/244 (100.00%)   46/93 (49.46%)   48/92 (52.17%)   14/73 (19.18%)   73/73 (100.00%) 
General disorders             
Oedema peripheral * 1  4/81 (4.94%)  113/244 (46.31%)  4/93 (4.30%)  6/92 (6.52%)  0/73 (0.00%)  34/73 (46.58%) 
Arthralgia * 1  14/81 (17.28%)  95/244 (38.93%)  5/93 (5.38%)  8/92 (8.70%)  2/73 (2.74%)  30/73 (41.10%) 
Pain in extremity * 1  3/81 (3.70%)  46/244 (18.85%)  5/93 (5.38%)  2/92 (2.17%)  2/73 (2.74%)  19/73 (26.03%) 
Headache * 1  3/81 (3.70%)  39/244 (15.98%)  4/93 (4.30%)  5/92 (5.43%)  0/73 (0.00%)  8/73 (10.96%) 
Myalgia * 1  3/81 (3.70%)  34/244 (13.93%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  14/73 (19.18%) 
Blood glucose increased * 1  2/81 (2.47%)  33/244 (13.52%)  3/93 (3.23%)  6/92 (6.52%)  2/73 (2.74%)  11/73 (15.07%) 
Hypoaesthesia * 1  0/81 (0.00%)  34/244 (13.93%)  1/93 (1.08%)  5/92 (5.43%)  0/73 (0.00%)  8/73 (10.96%) 
Paraesthesia * 1  3/81 (3.70%)  25/244 (10.25%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  5/73 (6.85%) 
Fatigue * 1  1/81 (1.23%)  23/244 (9.43%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  6/73 (8.22%) 
Insomnia * 1  2/81 (2.47%)  22/244 (9.02%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Joint stiffness * 1  0/81 (0.00%)  22/244 (9.02%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  4/73 (5.48%) 
Back pain * 1  4/81 (4.94%)  15/244 (6.15%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  3/73 (4.11%) 
Musculoskeletal stiffness * 1  1/81 (1.23%)  18/244 (7.38%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  9/73 (12.33%) 
Upper respiratory tract infection * 1  6/81 (7.41%)  13/244 (5.33%)  15/93 (16.13%)  7/92 (7.61%)  0/73 (0.00%)  0/73 (0.00%) 
Hyperglycaemia * 1  1/81 (1.23%)  17/244 (6.97%)  0/93 (0.00%)  0/92 (0.00%)  2/73 (2.74%)  10/73 (13.70%) 
Nausea * 1  3/81 (3.70%)  15/244 (6.15%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  3/73 (4.11%) 
Joint swelling * 1  0/81 (0.00%)  17/244 (6.97%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  5/73 (6.85%) 
Fluid retention * 1  0/81 (0.00%)  13/244 (5.33%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Injection site haemorrhage * 1  6/81 (7.41%)  7/244 (2.87%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Diarrhoea * 1  5/81 (6.17%)  7/244 (2.87%)  8/93 (8.60%)  4/92 (4.35%)  0/73 (0.00%)  0/73 (0.00%) 
Nasopharyngitis * 1  5/81 (6.17%)  6/244 (2.46%)  1/93 (1.08%)  5/92 (5.43%)  0/73 (0.00%)  0/73 (0.00%) 
Sinusitis * 1  4/81 (4.94%)  6/244 (2.46%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  0/73 (0.00%) 
Muscle spasms * 1  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  4/73 (5.48%) 
Shoulder pain * 1  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  1/73 (1.37%)  4/73 (5.48%) 
Swelling face * 1  0/81 (0.00%)  0/244 (0.00%)  0/93 (0.00%)  0/92 (0.00%)  0/73 (0.00%)  4/73 (5.48%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
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