Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12
| Group | Value (Square Centimeter (cm^2)) | Spread |
|---|---|---|
| Period I: Placebo | 0.5 | 34.5 |
| Period I: Serostim® 4 mg | -32.6 | 37.9 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Canada
1 trial · 1 completed · 1 with posted results
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
NCT0008262828 May 2004 to 28 Sept 2005
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.
Placebo comparator
Period I: Placebo
Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
Experimental
Period I: Serostim® 4 mg
Subjects will receive Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
Experimental
Period II: Serostim® 4 mg to Placebo
All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive placebo matched to Serostim® on alternate days for 24 weeks in Period II.
Experimental
Period II: Serostim® 4 mg to Serostim® 2 mg
All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive Serostim® 2 mg on alternate days for 24 weeks in Period II.
Experimental
Period II: Placebo to Placebo/Serostim® 4 mg
All subjects who will be initially randomized to Placebo arm in Period I continue receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.
Outcomes the sponsor listed as primary.
Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12
Time frame · Baseline, Week 12
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.
Treatment Period I: Change From Baseline in Trunk Fat at Week 12
Time frame · Baseline, Week 12
Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.
Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12
Time frame · Baseline, Week 12
Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.
Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12
Time frame · Baseline, Week 12
Lipid profile data was analyzed for Non-HDL Cholesterol.
Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I
Time frame · Week 36
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Square Centimeter (cm^2)) | Spread |
|---|---|---|
| Period I: Placebo | 0.5 | 34.5 |
| Period I: Serostim® 4 mg | -32.6 | 37.9 |
| Group | Value (Kilogram (Kg)) | Spread |
|---|---|---|
| Period I: Placebo | 0.2 | 1.3 |
| Period I: Serostim® 4 mg | -2.2 | 1.7 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Period I: Placebo | 0.23 | 1.42 |
| Period I: Serostim® 4 mg | 0.10 | 1.73 |
| Group | Value (milligram/deciliter (mg/dL)) | Spread |
|---|---|---|
| Period I: Placebo | -2.8 | 28.1 |
| Period I: Serostim® 4 mg | -13.0 | 37.1 |
| Group | Value (percentage of subjects) |
|---|---|
| Period II: Serostim® 4 mg to Placebo | 53.7 |
| Period II: Serostim® 4 mg to Serostim® 2 mg | 40.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Period I: Placebo (Week 1 to 12)Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. | – | 2 / 81 | 70 / 81 |
| Period I: Serostim® 4 mg (Week 1 to 12)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. | – | 3 / 244 | 244 / 244 |
| Period II: Serostim® 4 mg to Placebo (Week 12 to 36)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. | – | 3 / 93 | 46 / 93 |
| Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36)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. | – | 2 / 92 | 48 / 92 |
| Period II: Placebo to Placebo (Week 12 to Week 24)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. | – | 2 / 73 | 14 / 73 |
| Period II: Placebo to Serostim® 4 mg (Week 24 to 36)All subjects who were initially randomized to Placebo arm in Period I and received Serostim® 4 mg daily 12 weeks in Period II. | – | 1 / 73 | 73 / 73 |
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