Growth Hormone to Increase Immune Function in People With HIV

NCT00071240 | Completed Phase 2 DMC

• 1 other identifier: R01AI043864
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Growth Hormone; HIV; AIDS; Thymus; CD4 Cell; Immune System; Treatment Experienced

Outcome Measures

Primary Outcomes (2)

• Effect of 1 year of growth hormone treatment on thymus mass, naive and total T cells

  Thymus mass- months 0,6,12; Naive and total T cells - months 1,3,6,9,12

• TREC content in circulating lymphocytes

  Months 0,1,3,6,9,12

Secondary Outcomes (3)

• Effect of 1 year of growth hormone treatment on B cells, NK cells, CD34+ cells, activated T cells, circulating IGF-1 levels, circulating cytokine levels, T cell function and repertoire

  T cell repertoire Months 0,6,12, all others Months 0,1,3,6,9,12

• metabolic activity of thymus

  Months 0, 12

• body composition

  Months 0,3,6,12

Study Arms (2)

Growth Hormone Arm

EXPERIMENTAL

Growth hormone receipt in the first year, post-growth hormone follow-up in the second year

Drug: Somatropin (recombinant human growth hormone)

2

ACTIVE COMPARATOR

Observation only in the 1st year, GH receipt in the second year

Drug: Somatropin (recombinant human growth hormone)

Interventions

Somatropin (recombinant human growth hormone) DRUG

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

Also known as: Serostim

2; Growth Hormone Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• The J. David Gladstone Institutes: collaborator
• University of California, San Francisco: collaborator
• National Center for Research Resources (NCRR): collaborator
• EMD Serono: collaborator

Study Sites (1)

Gladstone Institute of Virology and Immunology

San Francisco, California, 94141, United States

Location

Related Publications (3)

• Napolitano LA, Lo JC, Gotway MB, Mulligan K, Barbour JD, Schmidt D, Grant RM, Halvorsen RA, Schambelan M, McCune JM. Increased thymic mass and circulating naive CD4 T cells in HIV-1-infected adults treated with growth hormone. AIDS. 2002 May 24;16(8):1103-11. doi: 10.1097/00002030-200205240-00003.

  PMID: 12004268 BACKGROUND

• Napolitano LA, Schmidt D, Gotway MB, Ameli N, Filbert EL, Ng MM, Clor JL, Epling L, Sinclair E, Baum PD, Li K, Killian ML, Bacchetti P, McCune JM. Growth hormone enhances thymic function in HIV-1-infected adults. J Clin Invest. 2008 Mar;118(3):1085-98. doi: 10.1172/JCI32830.

  PMID: 18292808 RESULT

• Tesselaar K, Miedema F. Growth hormone resurrects adult human thymus during HIV-1 infection. J Clin Invest. 2008 Mar;118(3):844-7. doi: 10.1172/JCI35112.

  PMID: 18292816 RESULT

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Human Growth Hormone; Growth Hormone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Laura A. Napolitano, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Joseph M. McCune, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 16, 2003
• First Posted: October 17, 2003
• Study Start: October 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 17, 2009

Record last verified: 2009-08

Locations

US (1)