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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Physiologic Growth Hormone Effects in HIV Lipodystrophy

NCTNCT00100698 (opens ClinicalTrials.gov in a new tab)Other idDK63639Other idR01DK063639

Overview

Status
Completed
Phase
Not applicable
Enrollment
56 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2004
Primary completion
Oct 2007
Completion
Apr 2009
First posted
5 Jan 2005 (estimated)
Last update posted
27 Jul 2010 (estimated)
Conditions
AIDS · HIV Infections

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200520062007200820092010
  1. N/A

    Physiologic Growth Hormone Effects in HIV Lipodystrophy

    NCT00100698

    Jan 2004 to Apr 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • recombinant human growth hormoneDrug
  • placeboDrug

Arms2

  • Active comparator

    1

    recombinant human growth hormone subcutaneously once a day

  • Placebo comparator

    2

    placebo subcutaneously once a day

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 18 months

    Registry description

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

Secondary outcomes(17)
  1. Change in Insulin-like Growth Factor-I From Baseline to 18 Months

    Time frame · 18 months

    Registry description

    Change in insulin-like growth factor-1

  2. Change in Trunk Fat

    Time frame · 18 months

  3. Change in Fasting Glucose

    Time frame · 18 months

    Registry description

    change in fasting glucose

  4. Change in Trunk to Extremity Ratio

    Time frame · 18 months

    Registry description

    change in trunk to extremity ratio

  5. Change in Triglycerides

    Time frame · 18 months

    Registry description

    Change in triglycerides

  6. Change in Subcutaneous Adipose Tissue

    Time frame · 18 months

    Registry description

    Change in subcutaneous adipose tissue

  7. Change in CD4 Cells

    Time frame · 18 months

    Registry description

    Change in CD4 cells

  8. Change in Logarithm HIV Viral Load

    Time frame · 18 months

    Registry description

    Change in logarithm base 10 HIV viral load

  9. Change in Lean Body Mass

    Time frame · 18 months

    Registry description

    change in lean body mass

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

    Time frame · 18 months

    Registry description

    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.

  11. Change in Diastolic Blood Pressure

    Time frame · 18 months

    Registry description

    Change in diastolic blood pressure

  12. Change in Adiponectin

    Time frame · 18 months

    Registry description

    Change in adiponectin

  13. Change in Carotid Intima Media Thickness (IMT)

    Time frame · 18 months

    Registry description

    change in carotid intima media thickness (IMT)

  14. Change in Body Mass Index

    Time frame · 18 months

    Registry description

    Change in body mass index

  15. Change in Extremity Fat

    Time frame · 18 months

    Registry description

    Change in extremity fat

  16. Change in 2-hour Glucose

    Time frame · 18 months

    Registry description

    Change in 2-hour glucose

  17. Change in Systolic Blood Pressure

    Time frame · 18 months

    Registry description

    Change in systolic blood pressure

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 18 months

Change in Visceral Adipose Tissue Area From Baseline to 18 Months

GroupValue (centimeters squared)Spread
Recombinant Human Growth Hormone-226
Placebo-44
Secondary and other outcome results(7)
Secondary outcomeMean· 18 months

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

GroupValue (nanograms/milliliter)Spread
Recombinant Human Growth Hormone10911
Placebo-258
Secondary outcomeMean· 18 months

Change in Trunk Fat

GroupValue (kilograms)Spread
Recombinant Human Growth Hormone-0.50.2
Placebo0.20.2
Secondary outcomeMean· 18 months

Change in Fasting Glucose

GroupValue (mg/dL)Spread
Recombinant Human Growth Hormone61
Placebo51
Secondary outcomeMean· 18 months

Change in Trunk to Extremity Ratio

GroupValue (kilogram per kilogram)Spread
Recombinant Human Growth Hormone-0.40.1
Placebo00
Secondary outcomeMedian· 18 months

Change in Triglycerides

GroupValue (mg/dL)
Recombinant Human Growth Hormone-7
Placebo0
Secondary outcomeMean· 18 months

Change in Subcutaneous Adipose Tissue

GroupValue (centimeters squared)Spread
Recombinant Human Growth Hormone44
Placebo44
Secondary outcomeMean· 18 months

Change in CD4 Cells

GroupValue (cells/microliter)Spread
Recombinant Human Growth Hormone-1913
Placebo1521

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Recombinant Human Growth Hormonerecombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously–4 / 263 / 26
Placeboplacebo subcutaneously once a day–1 / 295 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLo 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. PMID 18677023

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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