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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 3
Enrollment
326 participants (actual)
Sponsor
EMD Serono · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
28 May 2004
Primary completion
28 Sept 2005
Completion
28 Sept 2005
First posted
17 May 2004 (estimated)
Last update posted
20 Jul 2018
Conditions
HIV Infections · Lipodystrophy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006
  1. Ph 3

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

    NCT00082628

    28 May 2004 to 28 Sept 2005

Registry summary

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.

Interventions

  • PlaceboDrug
  • Serostim® 4 mgDrug
  • Serostim® 2 mgDrug

Arms5

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12

    Time frame · Baseline, Week 12

    Registry 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.

Secondary outcomes(4)
  1. Treatment Period I: Change From Baseline in Trunk Fat at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.

  2. Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.

  3. Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Lipid profile data was analyzed for Non-HDL Cholesterol.

  4. 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

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, Week 12

Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12

GroupValue (Square Centimeter (cm^2))Spread
Period I: Placebo0.534.5
Period I: Serostim® 4 mg-32.637.9
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline, Week 12

Treatment Period I: Change From Baseline in Trunk Fat at Week 12

GroupValue (Kilogram (Kg))Spread
Period I: Placebo0.21.3
Period I: Serostim® 4 mg-2.21.7
Secondary outcomeMean· Baseline, Week 12

Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12

GroupValue (units on a scale)Spread
Period I: Placebo0.231.42
Period I: Serostim® 4 mg0.101.73
Secondary outcomeMean· Baseline, Week 12

Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12

GroupValue (milligram/deciliter (mg/dL))Spread
Period I: Placebo-2.828.1
Period I: Serostim® 4 mg-13.037.1
Secondary outcomeNumber· Week 36

Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I

GroupValue (percentage of subjects)
Period II: Serostim® 4 mg to Placebo53.7
Period II: Serostim® 4 mg to Serostim® 2 mg40.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 8170 / 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 / 244244 / 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 / 9346 / 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 / 9248 / 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 / 7314 / 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 / 7373 / 73

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Have written laboratory documentation of an HIV infection by one of the following methods: * Detectable viral load measured by polymerase chain reaction (PCR) amplification, branched chain DNA (bDNA) signal amplification or the presence of p24 antigen. * Presence of HIV antibodies confirmed by either Western blot or immunofluorescence assay. Written laboratory documentation of an HIV infection must be obtained prior to randomization. In the absence of documented historical confirmation, an assay of HIV antibodies will be included in the Screening Laboratory Panel. Results will be confirmed with a Western Blot. 2. Have evidence of excess abdominal adipose deposition when measured by the anthropometric methodology, using the following cut off values: * Men: Waist circumference \>88.2 cm AND waist: hip ratio \>= 0.95. * Women: Waist circumference \>75.3 cm AND waist: hip ratio \>= 0.9. 3. Are taking antiretroviral medication(s) which is (are) approved or is (are) available under a Treatment IND. The regimen must have remained stable for 30 days prior to study entry. Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary. 4. Have parameter values less than the following limits (using results from the central laboratory): * AST, ALT, and amylase \<= 3 times the upper limit of normal (Screening). * Fasting triglycerides \<= 1,000 mg/dL (Screening). * Fasting glucose \<110 mg/dL (Screening). * Two-hour (120 minute) glucose \<140 mg/dL (Screening). 5. Weight \>= 36 kg (79.3 lb) 6. Be between 18 and 60 years of age (inclusive) unless local law dictates different limits. 7. Sufficiently literate in English to be able to comprehend and complete the Quality of Life Questionnaire. 8. Willing and able to comply with the protocol for the duration of the study. 9. Have voluntarily provided written informed consent (with subject authorization under HIPAA), prior to performing any study-related procedure that is not part of normal medical care, and with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. 10. Female subjects must: 1. Be post menopausal (\>= 1 year) or surgically sterilized (i.e., have undergone tubal ligation or hysterectomy) or 2. Use a contraceptive method for the duration of the study such as: * Hormonal contraceptive * Intra uterine device * Diaphragm with spermicide, or condom with spermicide. And 3. Must be neither pregnant nor breast feeding. 4. Confirmation that female subjects of childbearing potential are not pregnant must be established by a negative beta-hCG serum pregnancy test during the 14-day screening period prior to Study Day 1. If the beta-hCG serum pregnancy test is performed more than 7 days prior to Study Day 1, a urine pregnancy test must be performed by the site laboratory on Study Day 1 to confirm a negative test result. Exclusion Criteria: 1. Have an active AIDS-defining opportunistic complication (OC) as defined by the CDC or have had an untreated or suspected serious systemic infection, or have had a persistent fever \>= 101°F (38.3°C) during the 30 days prior to study entry. 2. Any active or past history of malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy). Such exceptions must be confirmed in writing by the Serono Study Director. 3. Have a CNS mass or active CNS process associated with neurological findings. 4. Have unstable or untreated hypertension, defined as \>= 140/90 mm Hg at the time of the Screening Visit, and/or have initiated or changed antihypertensive therapy in the 30 days prior to Study Day 1. 5. Have an acute critical illness treated in an intensive care unit, e.g., due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. 6. Have a recent history of sleep apnea or intermittent upper respiratory obstruction. 7. Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia. 8. Are unable to comply with the Concomitant Therapy restrictions including: * therapy for obesity including therapy with anorexigenic or fat reducing drugs * anti-diabetic or insulin sensitizing medications * systemic glucocorticoids * systemic chemotherapy, interferon or radiation therapy treatment * androgenic agents including, but not limited to testosterone, nandrolone, oxandrolone, oxymetholone, etc. (testosterone replacement therapy for hypogonadism is the exception to this exclusion and will be allowed if started \> 30 days prior to Study Day 1) * progestational agents, unless used for oral contraception or post-menopausal hormone replacement therapy * appetite stimulants * investigational agents, unless approved in advance by the study medical director. Specifically, experimental antiretroviral agents are disallowed, unless available under a treatment IND or expanded access program (30 days). * Liposuction or other elective plastic surgery * AIDS wasting therapy or prior growth hormone treatment other than study drug (for 12 months prior to the screening visit) 9. Have ever been diagnosed with any of the following conditions: * Pancreatitis * Carpal tunnel syndrome (unless resolved by surgical release) * Diabetes mellitus * Angina pectoris * Coronary artery disease * Any disorder associated with moderate to severe edema (e.g., ascites, nephrotic syndrome, congestive heart failure, lymphedema). 10. Allergy or hypersensitivity to growth hormone. 11. Are participating in any other clinical studies. In order to participate in this trial a subject must meet all of the inclusion and exclusion criteria specified above. Requests for protocol exceptions/exemptions must come from a participating, fully initiated site at which a prospective patient has consented to undergo screening. Exceptions/exemptions are only allowed by the Trial Director. There is no program in place to allow drug for a single patient IND, or for an expanded access protocol. This statement holds true for both children and adults.

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