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AIDSNCT00100698

Physiologic Growth Hormone Effects in HIV Lipodystrophy

A study testing recombinant human growth hormone in people with AIDS and HIV Infections, run by Massachusetts General Hospital at 1 site in United States.

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 will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
AIDS, HIV Infections
What is being tested?
recombinant human growth hormone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
Jan 2004to Apr 2009
Phase
Interventional
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

  • Men and women age 18-60
  • Previously diagnosed HIV infection
  • Stable antiviral regimen for at least 12 weeks prior to enrollment
  • Waist-to-hip ratio >0.90 for men and >0.85 for women
  • Evidence of at least one of the following recent changes: *increased abdominal girth,
  • relative loss of fat in the extremities, relative loss of fat in the face
  • Simulated peak GH response to arginine/GHRH of less than 7.5 mcg/dL

Who cannot join

  • Use of Megace, anti-diabetic agents, GH, or other anabolic agents, pharmacologic glucocorticoid (prednisone >5 mg/day or its equivalent) for 3 months prior to enrollment. Patients on a standard dose of testosterone for documented hypogonadism will be allowed to enter the protocol. Women taking standard estrogen replacement therapy for >3 months will be allowed in the study.
  • Diabetes mellitus
  • Other severe chronic illness
  • HgB <9.0 g/dL, creatinine >1.4 mg/dL, or PSA >4 ng/mL
  • Positive BHCG or failure to use appropriate birth control during study. Acceptable methods include oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, IUD's, barrier devices (condoms, diaphragms), and abstinence.
  • Carpal tunnel syndrome
  • Active malignancy or history of pituitary malignancy, history of colon cancer or prostate malignancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MGH

    Boston, Massachusetts, 02114

Other trials in United States

About this study

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

Read the detailed description

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.

Conditions
AIDS, HIV Infections
Being tested
recombinant human growth hormone, placebo
Keywords
HIV, lipodystrophy, growth hormone, visceral fat, IGF-I, Treatment Experienced
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections, Lipodystrophy

What participants receive

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

  • recombinant human growth hormoneDrug

    Also called Serostim

    growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months

  • placeboDrug

    placebo subcutaneously once a day, 18 months

Study groups in NCT00100698
Study groupRoleWhat they receive
1Active comparatorrecombinant human growth hormone subcutaneously once a day
Receives: Drug: recombinant human growth hormone
2Placebo comparatorplacebo subcutaneously once a day
Receives: Drug: placebo

What is being measured

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

  1. Change in Visceral Adipose Tissue Area From Baseline to 18 Months

    change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan

    Measured: 18 months

Secondary outcomes (17)

  1. Change in Insulin-like Growth Factor-I From Baseline to 18 Months

    Change in insulin-like growth factor-1

    Measured: 18 months

  2. Change in Trunk Fat

    Measured: 18 months

  3. Change in Fasting Glucose

    change in fasting glucose

    Measured: 18 months

  4. Change in Trunk to Extremity Ratio

    change in trunk to extremity ratio

    Measured: 18 months

  5. Change in Triglycerides

    Change in triglycerides

    Measured: 18 months

  6. Change in Subcutaneous Adipose Tissue

    Change in subcutaneous adipose tissue

    Measured: 18 months

  7. Change in CD4 Cells

    Change in CD4 cells

    Measured: 18 months

  8. Change in Logarithm HIV Viral Load

    Change in logarithm base 10 HIV viral load

    Measured: 18 months

  9. Change in Lean Body Mass

    change in lean body mass

    Measured: 18 months

  10. Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months

    Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.

    Measured: 18 months

  11. Change in Diastolic Blood Pressure

    Change in diastolic blood pressure

    Measured: 18 months

  12. Change in Adiponectin

    Change in adiponectin

    Measured: 18 months

  13. Change in Carotid Intima Media Thickness (IMT)

    change in carotid intima media thickness (IMT)

    Measured: 18 months

  14. Change in Body Mass Index

    Change in body mass index

    Measured: 18 months

  15. Change in Extremity Fat

    Change in extremity fat

    Measured: 18 months

  16. Change in 2-hour Glucose

    Change in 2-hour glucose

    Measured: 18 months

  17. Change in Systolic Blood Pressure

    Change in systolic blood pressure

    Measured: 18 months

Timeline

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

  1. First posted5 Jan 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionOct 2007
  4. Study completionApr 2009

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100698
Sponsor's protocol ID
DK63639
Other IDs
R01DK063639
Status last verified
Jul 2010
First submitted
4 Jan 2005
Last updated
27 Jul 2010
Data monitoring committee
Yes

Publications

  • Lo J, You SM, Canavan B, Liebau J, Beltrani G, Koutkia P, Hemphill L, Lee H, Grinspoon S. Low-dose physiological growth hormone in patients with HIV and abdominal fat accumulation: a randomized controlled trial. JAMA. 2008 Aug 6;300(5):509-19. doi: 10.1001/jama.300.5.509.

    PubMed 18677023

Questions about this trial

What is this clinical trial studying?

A study testing recombinant human growth hormone in people with AIDS and HIV Infections, run by Massachusetts General Hospital at 1 site in United States.

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 7 inclusion and 7 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 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 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 in Visceral Adipose Tissue Area From Baseline to 18 Months (time frame: 18 months). 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 NCT00100698, 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 27 Jul 2010.

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