Physiologic Growth Hormone Effects in HIV Lipodystrophy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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

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AIDS HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

recombinant human growth hormone subcutaneously once a day

Group Type ACTIVE_COMPARATOR

recombinant human growth hormone

Intervention Type DRUG

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

2

placebo subcutaneously once a day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo subcutaneously once a day, 18 months

Interventions

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recombinant human growth hormone

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

Intervention Type DRUG

placebo

placebo subcutaneously once a day, 18 months

Intervention Type DRUG

Other Intervention Names

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Serostim

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No