Overview

Growth Hormone to Increase Immune Function in People With HIV

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
EMD Serono
National Center for Research Resources (NCRR)
The J. David Gladstone Institutes
University of California, San Francisco
Treatments:
Hormones
Criteria
Inclusion Criteria:

- HIV infected

- CD4 count 400 cells/mm3 or less

- HIV viral load less than 1000 copies/ml for 1 year prior to study entry; in some
cases, viral load up to 5000 copies/ml will be acceptable

- Taking at least 2 anti-HIV medications

Exclusion Criteria:

- Diabetes

- Cancer. Patients with some cases of Kaposi's sarcoma or skin cancer will not be
excluded.

- Some (not all) forms of heart disease

- Carpal Tunnel Syndrome

- Pregnant or breastfeeding