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HIV InfectionsPhase 3NCT00489528

Growth Hormone in the Treatment of HIV-Associated Wasting

A Phase 3 study testing Somatropin; Recombinant human growth hormone (r hGH) in people with HIV Infections and HIV Wasting Syndrome, 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

The purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, HIV Wasting Syndrome
What is being tested?
Somatropin; Recombinant human growth hormone (r hGH)
How many people
Not given
Where
No sites listed yet
Study dates
Jul 1997to Mar 2002
Phase
Phase 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 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Have clearly documented HIV infection, determined by the presence of HIV confirmed by one of the following: Western blot, immunofluorescence assay, HIV culture, polymerase chain reaction (PCR) amplification, branched DNA (bDNA) signal amplification or 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 Serono prior to entry into the study.
  • Have evidence of AIDS wasting, with at least one of the following:
  • Documented unintentional weight loss of at least 10%, or
  • In the absence of unintentional weight loss of 10%, weight less than 90% of ideal body weight (Metropolitan Height and Weight Tables), or
  • In the absence of unintentional weight loss of 10%, body mass index < 20 kg/m².
  • Be at least 18 years of age.
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  • Be receiving at least 90% of estimated caloric requirement on current nutritional regimen, according to a formal nutritional analysis.
  • Meet the following laboratory testing criteria at the week -4 visit (pre study screening):
  • AST, ALT, and amylase < 3 times the upper limit of normal.
  • Fasting triglyceride level < 500 mg/dl (or <5.64 mmol/l).
  • Fasting glucose < 110 mg/dl (or < 6.1mmol/l).
  • Be taking an antiretroviral medication that is approved or available under a Treatment IND (in the US) or a temporary approval (outside the US).
  • The subject must have been on the antiretroviral therapy for at least 8 weeks prior to study Day 1.
  • The subject must agree not to change the antiviral regimen during the 12 weeks of study drug administration (unless medically mandated).
  • Be capable of completing all required study activities and assessments (including all required exercise performance tests).
  • Understand and sign an informed consent document.

Who cannot join

  • Any medical history of the following:
  • Pancreatitis.
  • Carpal tunnel syndrome (unless resolved by surgical release).
  • Glucose intolerance [for the purpose of this protocol defined as fasting blood glucose ≥ 110 mg/dl (6.1 mmol/l), or 2 hour/random blood glucose ≥ 140 mg/dl (7.8 mg/dl)].
  • Angina pectoris.
  • Coronary artery disease.
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  • Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure, lymphedema).
  • Allergy or hypersensitivity to growth hormone.
  • Any of the following medical conditions:
  • Active AIDS-defining opportunistic infection.
  • Any active malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which exceeds 2 cm in size, not on active therapy).
  • A central nervous system (CNS) mass, or CNS process associated with active neurological findings.
  • Chronic diarrhea (defined as 6 or more liquid stools per day).
  • Unstable or untreated hypertension.
  • Patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure.
  • Either of the following aspects of the medical regimen in the 30 days prior to study entry (60 days prior to receiving study drug):
  • New systemic therapy for opportunistic infection.
  • New therapy for wasting, including parenteral or oral hyperalimentation, tube feeding, anabolic or progestational agents, or appetite stimulants.
  • Prior radiation therapy or systemic chemotherapy.
  • Use of glucocorticoids within the past six months or growth hormone within the past year.
  • An untreated or suspected serious systemic infection, or persistent fever > 101°F (or 38.5°C) during the 30 days prior to study entry.
  • Evidence of gastrointestinal (GI) bleeding, obstruction, or malabsorption as determined by the Investigator.
  • Active substance abuse which would prevent informed consent or compliance with study activities.
  • Dementia which would preclude the patient from giving informed consent or complying with the requirements of this protocol.
  • If female, be neither pregnant or breast feeding.
  • Use of an investigational agent under another protocol unless discussed and approved in advance by Serono's Therapeutic Director.

About this study

Official title: A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Recombinant Human Growth Hormone (Serostim) in the Treatment of HIV-Associated Catabolism/Wasting

The purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug.

Being tested
Somatropin; Recombinant human growth hormone (r hGH)
Keywords
serostim, Dose-Response Relationship, Drug, Body Composition
Medical subject headings
HIV Infections, HIV Wasting Syndrome

What participants receive

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

  • Somatropin; Recombinant human growth hormone (r hGH)Drug

What is being measured

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

  1. To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.

Secondary outcomes (1)

  1. To establish an optimal dose of Serostim, based on the endpoint of lean body mass (LBM) change.

Timeline

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

  1. First posted21 Jun 2007 (estimated)
  2. Study startJul 1997
  3. Study completionMar 2002

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00489528
Sponsor's protocol ID
9037
Status last verified
Oct 2013
First submitted
20 Jun 2007
Last updated
22 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Somatropin; Recombinant human growth hormone (r hGH) in people with HIV Infections and HIV Wasting Syndrome, 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 16 inclusion and 26 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 22 Oct 2013. 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. 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?

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?

To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.. 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 NCT00489528.

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 22 Oct 2013.

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