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Growth Hormone to Increase Immune Function in People With HIV

NCT00071240 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2009-08-17

No results posted yet for this study

Summary

Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV.

Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.

Conditions

  • HIV Infections

Interventions

DRUG

Somatropin (recombinant human growth hormone)

3.0mg sc daily for 6 months, followed by 1.5mg sc daily for 6 months. Dose stopped, held or reduced by study investigators as indicated by adverse events

Sponsors & Collaborators

  • The J. David Gladstone Institutes

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • EMD Serono

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Laura A. Napolitano, MD · University of California, San Francisco

  • Joseph M. McCune, MD, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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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 NCT00071240 on ClinicalTrials.gov