Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)Phase 2/3NCT00294164

Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)

A Phase 2/3 study testing Serostim® in people with Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) and Human Immunodeficiency Virus Infections, run by EMD Serono.

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

This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group, placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency virus-associated adipose tissue redistribution syndrome (HARS). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections
What is being tested?: Serostim®
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 245 participants
Where: No sites listed yet
Study dates: Mar 2001to May 2002
Phase: Phase 2/3
Are there results?: None posted in the registry

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 an Human Immunodeficiency Virus (HIV) infection documented either by viral load as measured by polymerase chain reaction (PCR) amplification; or by the presence of HIV antibodies with confirmation by one of the following:
Western blot
Immunofluorescence assay
Branched Deoxyribonucleic Acid (bDNA) signal amplification
The presence of p24 antigen
These tests may have been performed at any time in the past, but the results must be available for review by the Serono monitor prior to randomization

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Have evidence of excess abdominal adipose deposition when measured using the following cut points:
Men: Waist circumference greater than 88.2 centimeter (cm) and waist/hip ratio greater than or equal to 0.95
Women: Waist circumference greater than 75.3 cm and waist/hip ratio greater than or equal to 0.9 (23)
Be taking antiretroviral medication(s) which is (are) approved or is (are) available under a treatment investigational new drug (IND). The regimen must have remained stable for the 30 days prior to study entry. Subjects must also have agreed 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:
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and amylase less than or equal to 3 times the upper limit of normal (Screening)
Fasting triglycerides less than or equal to 1,000 milligram per deciliter (mg/dL) (Screening)
Fasting glucose less than 110 mg/dL (Screening)
Two hour (120 minute) glucose less than 140 mg/dL (following an oral glucose load at Screening)
Weigh greater than or equal to 36 kilogram (kg) (79.3 pound)
Be between 18 and 60 years of age unless local law dictates different limits
Be able and willing to comply with the protocol for the duration of the study
Have given written informed consent
If female, be post-menopausal or surgically sterilized (that is, have undergone tubal ligation or hysterectomy), or is
Using a contraceptive method such as a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
Not pregnant or breast feeding

Who cannot join

Have an active acquired immune deficiency syndrome (AIDS)-defining Opportunistic Infection (OI) as defined by the Center for Disease Control; or have had an untreated or suspected serious systemic infection, or persistent fever greater than or equal to 101 degree Fahrenheit (°F) (38.3 degree Celsius) during the 30 days prior to study entry
Have any active malignancy, except for localized cutaneous Karposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy)
Have a central nervous system (CNS) mass or active CNS process associated with neurological findings
Have unstable or untreated hypertension, defined as greater than or equal to 140/90 millimeter of mercury (mmHg) at the time of the Screening Visit, and/or has initiated or changed antihypertensive therapy in the 30 days prior to Day 1
Have an acute critical illness treated in an intensive care unit, for example, due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure
Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia

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Is unable to comply with the concomitant therapy restrictions
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 (for example, cirrhosis, nephrotic syndrome, congestive heart failure, lymphedema)
Allergy or hypersensitivity to growth hormone

About this study

Official title: Phase 2/3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Safety and Efficacy Trial of Subcutaneously Administered Serostim® (Mammalian Cell-derived Recombinant Human Growth Hormone, r-hGH) in the Treatment of Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)

The primary study objective is to determine whether Serostim® treatment reduces adipose tissue maldistribution more effectively than placebo. The primary co-endpoints are derived from measures of visceral adipose tissue assessed by computerized tomography (CT) and the ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans. Anthropometric measures, physical exams, quality of life assessments, serial photographs, and various laboratory measures will be used to address secondary objectives. These secondary objectives relate to the impact of Serostim® on Physician and subject assessments of change in body shape, health-related quality of life, attitude towards medication compliance, metabolic markers, fat redistribution, and safety.

On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive daily Serostim®, Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be based on body weight, with a maximum dose of 4 milligram (mg).

Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4 (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to be enrolled into a maintenance Protocol (Study 23056) at Week 24.

Conditions: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections
Being tested: Serostim®, Placebo
Keywords: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections, recombinant human growth hormone (r-hGH), Serostim®, Placebo

What participants receive

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

Serostim®Drug
Also called Recombinant human growth hormone (r-hGH)
Serostim® will be administered subcutaneously (daily or given on alternate days with matched placebo), at a dose based on body weight measured at Baseline, with a maximum daily dose of 4 mg up to Week 24.
PlaceboDrug
Matching placebo will be administered subcutaneously (daily or given on alternate days with Serostim®), up to Week 24.

Study groups in NCT00294164
Study group	Role	What they receive
Serostim® 4 mg daily	Experimental	Not described Receives: Drug: Serostim®
Serostim® 4 mg alternate days	Experimental	Not described Receives: Drug: Serostim®; Drug: Placebo
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12
Measured: Baseline and Week 12
Change from Baseline in the ratio of trunk fat to limb fat quantified by Dual-Energy X-Ray Absorptiometry (DXA) scan at Week 12
Measured: Baseline and Week 12

Secondary outcomes (14)

Change from Baseline in composite sum of the visceral adipose tissue and the ratio of trunk fat to limb fat at Week 12
Measured: Baseline and Week 12
Dorsal fat area in the transverse plane, as measured by Computerized Tomography (CT) Scan
Measured: Baseline, Week 12 and 24
Weight measured on a calibrated scale
Measured: Baseline, Week 12 and 24
Absolute values of maximal chest, waist, and hip circumference
Measured: Baseline, Week 12 and 24
Waist/hip ratio
Measured: Baseline, Week 12 and 24
Absolute value of dorsocervical fat
Measured: Baseline, Week 12 and 24
Absolute value of total body fat as quantified by DXA scan
Measured: Baseline, Week 12 and 24
Absolute value of trunk and Limb fat quantified by DXA scan
Measured: Baseline, Week 12 and 24
Absolute value of Lean body mass as quantified by DXA scan
Measured: Baseline, Week 12 and 24
Absolute concentration of serum insulin and glucose
Measured: Baseline, Week 12 and 24
Absolute concentration of fasting serum triglyceride, total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL) and very low density lipoprotein (VLDL)
Measured: Baseline, Week 12 and 24
High density lipoprotein (HDL)/Low density lipoprotein (LDL) ratio
Measured: Baseline, Week 12 and 24
Change from Baseline in Serial Photography Parameters of chest and abdomen at Week 12 and 24
Measured: Baseline, Week 12 and 24
Health related Quality of life
Measured: Baseline, Week 4, 12 and 24

Timeline

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

Mar 2001May 2002

First posted20 Feb 2006 (estimated)
Study startMar 2001
Primary completionMay 2002
Study completionMay 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)Studies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00294164
Sponsor's protocol ID: 22388
Status last verified: Mar 2014
First submitted: 16 Feb 2006
Last updated: 26 Mar 2014
Results posted: No

Publications

Kotler DP, Muurahainen N, Grunfeld C, Wanke C, Thompson M, Saag M, Bock D, Simons G, Gertner JM; Serostim in Adipose Redistribution Syndrome Study Group. Effects of growth hormone on abnormal visceral adipose tissue accumulation and dyslipidemia in HIV-infected patients. J Acquir Immune Defic Syndr. 2004 Mar 1;35(3):239-52. doi: 10.1097/00126334-200403010-00004.
PubMed 15076238

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2/3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Safety and Efficacy Trial of Subcutaneously Administered Serostim® (Mammalian Cell-derived Recombinant Human Growth Hormone, r-hGH) in the Treatment of Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
ClinicalTrials.gov ID: NCT00294164
Acronym / sponsor ID: 22388
Conditions: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections
Keywords: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS), Human Immunodeficiency Virus Infections, recombinant human growth hormone (r-hGH), Serostim®, Placebo
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: EMD SeronoIndustry (pharma, biotech, devices)
Study start: Mar 2001
Primary completion: May 2002 (actual)
Study completion: May 2002 (actual)
First posted: 20 Feb 2006 (estimated)
Results: Not posted in the source record

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Serostim® 4 mg daily	Experimental	Drug: Serostim®
Serostim® 4 mg alternate days	Experimental	Drug: Serostim®, Drug: Placebo
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (22 listed)

Have an Human Immunodeficiency Virus (HIV) infection documented either by viral load as measured by polymerase chain reaction (PCR) amplification; or by the presence of HIV antibodies with confirmation by one of the following:
Western blot
Immunofluorescence assay
Branched Deoxyribonucleic Acid (bDNA) signal amplification
The presence of p24 antigen

Key exclusion criteria (15 listed)

Have an active acquired immune deficiency syndrome (AIDS)-defining Opportunistic Infection (OI) as defined by the Center for Disease Control; or have had an untreated or suspected serious systemic infection, or persistent fever greater than or equal to 101 degree Fahrenheit (°F) (38.3 degree Celsius) during the 30 days prior to study entry
Have any active malignancy, except for localized cutaneous Karposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy)
Have a central nervous system (CNS) mass or active CNS process associated with neurological findings
Have unstable or untreated hypertension, defined as greater than or equal to 140/90 millimeter of mercury (mmHg) at the time of the Screening Visit, and/or has initiated or changed antihypertensive therapy in the 30 days prior to Day 1
Have an acute critical illness treated in an intensive care unit, for example, 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
Serostim®Also: Recombinant human growth hormone (r-hGH)Serostim® will be administered subcutaneously (daily or given on alternate days with matched placebo), at a dose based on body weight measured at Baseline, with a maximum daily dose of 4 mg up to Week 24.	Drug	Serostim® 4 mg alternate days, Serostim® 4 mg daily
PlaceboMatching placebo will be administered subcutaneously (daily or given on alternate days with Serostim®), up to Week 24.	Drug	Placebo, Serostim® 4 mg alternate days

Primary outcome

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12
Time frame: Baseline and Week 12
Change from Baseline in the ratio of trunk fat to limb fat quantified by Dual-Energy X-Ray Absorptiometry (DXA) scan at Week 12
Time frame: Baseline and Week 12

14 secondary outcomes

Change from Baseline in composite sum of the visceral adipose tissue and the ratio of trunk fat to limb fat at Week 12
Time frame: Baseline and Week 12
Dorsal fat area in the transverse plane, as measured by Computerized Tomography (CT) Scan
Time frame: Baseline, Week 12 and 24
Weight measured on a calibrated scale
Time frame: Baseline, Week 12 and 24
Absolute values of maximal chest, waist, and hip circumference
Time frame: Baseline, Week 12 and 24
Waist/hip ratio
Time frame: Baseline, Week 12 and 24
Absolute value of dorsocervical fat
Time frame: Baseline, Week 12 and 24
Absolute value of total body fat as quantified by DXA scan
Time frame: Baseline, Week 12 and 24
Absolute value of trunk and Limb fat quantified by DXA scan
Time frame: Baseline, Week 12 and 24
Absolute value of Lean body mass as quantified by DXA scan
Time frame: Baseline, Week 12 and 24
Absolute concentration of serum insulin and glucose
Time frame: Baseline, Week 12 and 24
Absolute concentration of fasting serum triglyceride, total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL) and very low density lipoprotein (VLDL)
Time frame: Baseline, Week 12 and 24
High density lipoprotein (HDL)/Low density lipoprotein (LDL) ratio
Time frame: Baseline, Week 12 and 24
Change from Baseline in Serial Photography Parameters of chest and abdomen at Week 12 and 24
Time frame: Baseline, Week 12 and 24
Health related Quality of life
Time frame: Baseline, Week 4, 12 and 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Results publication: PubMed 15076238Kotler DP, Muurahainen N, Grunfeld C, Wanke C, Thompson M, Saag M, Bock D, Simons G, Gertner JM; Serostim in Adipose Redistribution Syndrome Study Group. Effects of growth hormone on abnormal visceral adipose tissue accumulation and dyslipidemia in HIV-infected patients. J Acquir Immune Defic Syndr. 2004 Mar 1;35(3):239-52. doi: 10.1097/00126334-200403010-00004.
Published in J Acquir Immune Defic Syndr 35; 239-252: 2004Link provided by the sponsor.
Full FDA approved prescribing information can be found hereLink provided by the sponsor.

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.

Ellen Brady, M.D. MPH study director

EMD Serono

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Serostim® in people with Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) and Human Immunodeficiency Virus Infections, run by EMD Serono.

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 22 inclusion and 15 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 NCT00294164, 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 26 Mar 2014.