HIV InfectionsPhase 3NCT00082628
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
A Phase 3 study testing Serostim® 4 mg and Serostim® 2 mg in people with HIV Infections and Lipodystrophy, run by EMD Serono at 31 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Lipodystrophy
- What is being tested?
- Serostim® 4 mg and Serostim® 2 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 28 May 2004to 28 Sep 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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.
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- Women: Waist circumference >75.3 cm AND waist: hip ratio >= 0.9.
- 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.
- 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).
- Weight >= 36 kg (79.3 lb)
- Be between 18 and 60 years of age (inclusive) unless local law dictates different limits.
- Sufficiently literate in English to be able to comprehend and complete the Quality of Life Questionnaire.
- Willing and able to comply with the protocol for the duration of the study.
- 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.
- Female subjects must:
- Be post menopausal (>= 1 year) or surgically sterilized (i.e., have undergone tubal ligation or hysterectomy)
- or
- 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
- Must be neither pregnant nor breast feeding.
- 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.
Who cannot join
- 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.
- 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.
- Have a CNS mass or active CNS process associated with neurological findings.
- 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.
- 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.
- Have a recent history of sleep apnea or intermittent upper respiratory obstruction.
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- Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
- 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)
- 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).
- Allergy or hypersensitivity to growth hormone.
- 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.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
Albany Medical College
Albany, New York, 12208
IDP Research
Annandale, Virginia, 22003
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Central Texas Clincial research
Austin, Texas, 78705
University of Alabama/Birmingham
Birmingham, Alabama, 35294
Tufts University School of Medicine
Boston, Massachusetts, 02111
Community Research Initiative of New England
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Office Of Dr Gary Richmond
Fort Lauderdale, Florida, 33316
Indiana University Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
CARE CLINIC - UCLA Medical Center
Los Angeles, California, 90095
3661 South Miami Avenue
Miami, Florida, 33133
Care Resources
Miami, Florida, 33137
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Weill Medical College of Cornell Universtiy
New York, New York, 10021
St. Luke's Roosevelt Hospital
New York, New York, 10025
1401 N. Palm Canyon
Palm Springs, California, 92262
Trials Unit Div of Infectious and Immunologic Diseases
Sacramento, California, 95817
UCSD - AntiViral Research Center
San Diego, California, 92103
University of California, San Francisco - Div. of Endocrinology
San Francisco, California, 94110
Kaiser Permanente
San Francisco, California, 94118
Northern California Institute for Research and Education, Inc.
San Francisco, California, 94121
Infectious Disease Associates
Sarasota, Florida, 34239
Office of Daniel Coulston, M.D.
Spokane, Washington, 99204
Community Research Initiative Of New England
Springfield, Massachusetts, 01107
Bronx Women's Interagency HIV Study
The Bronx, New York, 10467
Harbor-UCLA Medical Ctr Research & Education Institute
Torrance, California, 90502
1640 Rhode Island Avenue, N.W.
Washington D.C., District of Columbia, 20036
AIDS Alliance
West Hollywood, California, 90069
About this study
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Serostim®, r-hGH in the Treatment and Maintenance of Human Immunodeficiency HIV-Associated Adipose Redistribution Syndrome, or HARS
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.
- Conditions
- HIV Infections, Lipodystrophy
- Being tested
- Placebo, Serostim® 4 mg, Serostim® 2 mg
- Keywords
- Growth hormone, Serostim®, Human Adipose Redistribution Syndrome, Human Immunodeficiency Virus lipodystrophy
- Medical subject headings
- HIV Infections, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo matched to serostim® as subcutaneous injection.
Serostim® 4 mgDrug
Also called recombinant human growth hormone (r-hGH)
Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.
Serostim® 2 mgDrug
Also called recombinant human growth hormone (r-hGH)
Serostim® 2 mg as subcutaneous injection on alternate days.
| Study group | Role | What they receive |
|---|---|---|
| Period I: Placebo | Placebo comparator | Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. Receives: Drug: Placebo |
| Period I: Serostim® 4 mg | Experimental | 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. Receives: Drug: Serostim® 4 mg |
| Period II: Serostim® 4 mg to Placebo | Experimental | 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. Receives: Drug: Placebo |
| Period II: Serostim® 4 mg to Serostim® 2 mg | Experimental | 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. Receives: Drug: Serostim® 2 mg |
| Period II: Placebo to Placebo/Serostim® 4 mg | Experimental | 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. Receives: Drug: Placebo; Drug: Serostim® 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at 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.
Measured: Baseline, Week 12
Secondary outcomes (4)
Treatment Period I: Change From Baseline in Trunk Fat at Week 12
Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.
Measured: Baseline, Week 12
Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12
Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.
Measured: Baseline, Week 12
Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12
Lipid profile data was analyzed for Non-HDL Cholesterol.
Measured: Baseline, Week 12
Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I
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.
Measured: Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2004 (estimated)
- Study start28 May 2004
- Primary completion28 Sep 2005
- Study completion28 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082628
- Sponsor's protocol ID
- 24380
- Status last verified
- Sep 2017
- First submitted
- 13 May 2004
- Last updated
- 20 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Serostim®, r-hGH in the Treatment and Maintenance of Human Immunodeficiency HIV-Associated Adipose Redistribution Syndrome, or HARS
- ClinicalTrials.gov ID
- NCT00082628
- Acronym / sponsor ID
- 24380
- Conditions
- HIV Infections, Lipodystrophy
- Keywords
- Growth hormone, Serostim®, Human Adipose Redistribution Syndrome, Human Immunodeficiency Virus lipodystrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- 28 May 2004 (actual)
- Primary completion
- 28 Sep 2005 (actual)
- Study completion
- 28 Sep 2005 (actual)
- First posted
- 17 May 2004 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Period I: Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. |
| Period I: Serostim® 4 mg | Experimental | Drug: Serostim® 4 mgSubjects 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. |
| Period II: Serostim® 4 mg to Placebo | Experimental | Drug: PlaceboAll 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. |
| Period II: Serostim® 4 mg to Serostim® 2 mg | Experimental | Drug: Serostim® 2 mgAll 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. |
| Period II: Placebo to Placebo/Serostim® 4 mg | Experimental | Drug: Placebo, Drug: Serostim® 4 mgAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- Have written laboratory documentation of an HIV infection by one of the following methods:
- 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.
- Have evidence of excess abdominal adipose deposition when measured by the anthropometric methodology, using the following cut off values:
- 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.
- Have parameter values less than the following limits (using results from the central laboratory):
Key exclusion criteria (28 listed)
- 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.
- 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.
- Have a CNS mass or active CNS process associated with neurological findings.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo matched to serostim® as subcutaneous injection. | Drug | Period I: Placebo, Period II: Placebo to Placebo/Serostim® 4 mg, Period II: Serostim® 4 mg to Placebo |
| Serostim® 4 mgAlso: recombinant human growth hormone (r-hGH)Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight. | Drug | Period I: Serostim® 4 mg, Period II: Placebo to Placebo/Serostim® 4 mg |
| Serostim® 2 mgAlso: recombinant human growth hormone (r-hGH)Serostim® 2 mg as subcutaneous injection on alternate days. | Drug | Period II: Serostim® 4 mg to Serostim® 2 mg |
Primary outcome
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.
4 secondary outcomes
Treatment Period I: Change From Baseline in Trunk Fat at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12
Time frame: Baseline, Week 12
Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12
Time frame: Baseline, Week 12
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
- Link to PubMedLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serostim® 4 mg and Serostim® 2 mg in people with HIV Infections and Lipodystrophy, run by EMD Serono at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.