Human Immunodeficiency Virus-Associated Adipose Redistribution SyndromePhase 3NCT01077960

Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome

A Phase 3 study testing Serostim in people with Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome, run by EMD Serono at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
What is being tested?: Serostim
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 26 sitesin 2 countries
Study dates: Feb 2005to Jan 2006
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must meet all inclusion/exclusion criteria for Serono Study 25373, have participated in Serono Study 24380, must have been assigned to Group A, must have completed all treatments and procedures (including baseline, Week 12 and Week 36 Computerized Tomography (CT) and Dual-Energy X-ray Absorptiometry (DXA) Scans) and had no major protocol violation.
Must be taking antiretroviral medications that are approved or are available under a Treatment Investigational New Drug (IND). Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
Must be willing and able to comply with the protocol for the duration of the study.
Must have voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act of 1996 (HIPAA), prior to 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.
If female, subjects must either:
Be post menopausal (=/>1 year) or surgically sterilized (i.e., have undergone tubal ligation or hysterectomy), or

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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 pregnancy test prior to initiating first treatment.
A pregnancy test is not required if the subject is post menopausal or surgically sterilized.

Who cannot join

Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
Have any active malignancy, except localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy).
Have active central nervous system (CNS) process associated with neurological findings.
Have acute 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 any medical condition in view of which the study doctor and/or Serono Medical/Therapeutic Director feels that it would be in the best interest of the subject not to participate in the follow-up study.
Are unable to comply with the Concomitant Therapy restrictions as outlined in Section 5.5 and listed as follows:

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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 (Deca-durabolin), oxandrolone (Oxandrin), oxymetholone (Anadrol), dehydroepiandrosterone (DHEA), 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 of Serono Study 24380).
Progestational agents, unless used for oral contraception or post-menopausal hormone replacement therapy.
Appetite stimulants such as dronabinol (Marinol), megestrol acetate (Megace), or cyproheptadine (Periactin).
Investigational agents, unless approved in advance by Serono's 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.
Acquired Immune Deficiency Syndrome (AIDS) wasting therapy with growth hormone and/or prior treatment with growth hormone or a growth hormone releasing factor (for 12 months prior to the screening visit).
Are participating in any other clinical studies (except Serono Study 24380). Observation studies are allowed, but prior written permission by Serono Medical/Therapeutic Director must be granted.

Trial locations and contacts

26 sites in 2 countries.

Country

City, postcode or hospital

26 sites in 2 countries

United States25 sites

IPD Research
Annandale, Virginia
AIDS Research Consortium of Atlanta
Atlanta, Georgia
Central Texas Clinical Research
Austin, Texas
University of Alabama/Birmingham
Birmingham, Alabama
Community Research Initiative of New England
Boston, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts
Rush University Medical Center
Chicago, Illinois
Private Practice
Fort Lauderdale, Florida
Care Clinic
Los Angeles, California
Care Resources
Miami, Florida
Private Practice
Miami, Florida
Hennepin County Medical Center
Minneapolis, Minnesota
St. Luke's Roosevelt Hospital
New York, New York
St. Vincents Catholic Medical Center
New York, New York
Weill Medical College of Cornell University
New York, New York
Private Practice
North Miami Beach, Florida
Circle Medical LLC
Norwalk, Connecticut
Private Practice
Palm Beach, California
UCSD - AVRC (AntiViralResearchCenter)
San Diego, California
Kaiser Permanente
San Francisco, California
Infectious Disease Associates
Sarasota, Florida
Private Practice
Spokane, Washington
Harbor-UCLA Medical Center
Torrence, California
Private Practice
Washington D.C., District of Columbia
AIDS Alliance
West Hollywood, California

Other trials in United States

Canada1 site

St Paul Hospital
Vancouver, British Columbia

Other trials in Canada

About this study

Official title: Phase III, Multi-Center, Open, 12-Week, Follow-up Safety and Efficacy Study of Serostim® in Subjects With Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)

In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007).

In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.

Conditions: Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Being tested: Serostim
Keywords: Serostim, HARS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SerostimBiological
Also called mammalian cell-derived recombinant human growth hormone, r hGH
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)

Study groups in NCT01077960
Study group	Role	What they receive
Serostim	Experimental	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) Receives: Biological: Serostim

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
Measured: baseline to 12 weeks

Secondary outcomes (5)

Change From Baseline to Week 12 in Waist Circumference
Measured by anthropometry
Measured: baseline to 12 weeks
Change From Baseline to Week 12 in Insulin-like Growth Factor I
Circulating levels of IGF-I
Measured: baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin
Oral glucose tolerance testing
Measured: baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose
Oral glucose testing
Measured: baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose
Oral glucose testing
Measured: baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Jan 2006

First posted1 Mar 2010 (estimated)
Study startFeb 2005
Primary completionJan 2006
Study completionJan 2006

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency Virus-Associated Adipose Redistribution SyndromeStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01077960
Sponsor's protocol ID: 25373 (NCT01077960)
Status last verified: Aug 2013
First submitted: 26 Feb 2010
Last updated: 7 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Grunfeld C, Thompson M, Brown SJ, Richmond G, Lee D, Muurahainen N, Kotler DP; Study 24380 Investigators Group. Recombinant human growth hormone to treat HIV-associated adipose redistribution syndrome: 12 week induction and 24-week maintenance therapy. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):286-97. doi: 10.1097/QAI.0b013e3180691145.
PubMed 17592343

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III, Multi-Center, Open, 12-Week, Follow-up Safety and Efficacy Study of Serostim® in Subjects With Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
ClinicalTrials.gov ID: NCT01077960
Acronym / sponsor ID: 25373 (NCT01077960)
Conditions: Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Keywords: Serostim, HARS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: EMD SeronoIndustry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Jan 2006 (actual)
Study completion: Jan 2006 (actual)
First posted: 1 Mar 2010 (estimated)
Results: Posted 23 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Serostim	Experimental	Biological: SerostimSerostim® 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Must meet all inclusion/exclusion criteria for Serono Study 25373, have participated in Serono Study 24380, must have been assigned to Group A, must have completed all treatments and procedures (including baseline, Week 12 and Week 36 Computerized Tomography (CT) and Dual-Energy X-ray Absorptiometry (DXA) Scans) and had no major protocol violation.
Must be taking antiretroviral medications that are approved or are available under a Treatment Investigational New Drug (IND). Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
Must be willing and able to comply with the protocol for the duration of the study.
Must have voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act of 1996 (HIPAA), prior to 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.
If female, subjects must either:

Key exclusion criteria (17 listed)

Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
Have any active malignancy, except localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy).
Have active central nervous system (CNS) process associated with neurological findings.
Have acute 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 any medical condition in view of which the study doctor and/or Serono Medical/Therapeutic Director feels that it would be in the best interest of the subject not to participate in the follow-up study.

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
SerostimAlso: mammalian cell-derived recombinant human growth hormone, r hGHSerostim® 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)	Biological	Serostim

Primary outcome

Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan
Time frame: baseline to 12 weeks

5 secondary outcomes

Change From Baseline to Week 12 in Waist Circumference
Time frame: baseline to 12 weeks
Change From Baseline to Week 12 in Insulin-like Growth Factor I
Time frame: baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin
Time frame: baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose
Time frame: baseline to 12 weeks
Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose
Time frame: baseline to 12 weeks

Results and safety

Results posted to the registry on 23 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Serostim	126	110

Primary outcome: Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan

Time frame: baseline to 12 weeks. Mean (Standard Deviation). Unit: kg

Measure	Serostim n = 106
Value	-1.7 (1.4)

Serostim: p <0.001, t-test, 2 sided

Population analysed: The analysis population reported here comprised the subjects who received at least one dose of study drug

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Serostim	2 of 126 (1.6%)	89 of 126 (70.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17592343Grunfeld C, Thompson M, Brown SJ, Richmond G, Lee D, Muurahainen N, Kotler DP; Study 24380 Investigators Group. Recombinant human growth hormone to treat HIV-associated adipose redistribution syndrome: 12 week induction and 24-week maintenance therapy. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):286-97. doi: 10.1097/QAI.0b013e3180691145.

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.

The record lists no contact. Use the official record to reach the sponsor.

26 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 in people with Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome, run by EMD Serono at 26 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 10 inclusion and 17 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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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. 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 23 Jun 2010). 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?

Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01077960, which also lists 1 linked publication.

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 7 Aug 2013.