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Physiologic Growth Hormone Effects in HIV Lipodystrophy

NCT00100698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2010-07-27

Study results available
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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. 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.

Conditions

  • AIDS
  • HIV Infections

Interventions

DRUG

recombinant human growth hormone

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

DRUG

placebo

placebo subcutaneously once a day, 18 months

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

Principal Investigators

  • Steven Grinspoon, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-10-31
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00100698 on ClinicalTrials.gov