Growth Hormone to Increase Immune Function in People With HIV

August 14, 2009 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

The Use of Recombinant Growth Hormone to Enhance T-Cell Production in Adults Infected With HIV-1

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The thymus is the major organ of T cell production and is generally believed to be nonfunctional in adults. Even if nonfunctional, it is destroyed by HIV infection while T cells are destroyed in the peripheral lymphoid system. Given the absence of new T cell production and a pathologic acceleration of T cell destruction, the immune system collapses and immunodeficiency ensues.

However, some studies have demonstrated thymic function in adults with HIV disease. Such function may be induced by positive feedback regulation of T cell production and the presence or absence of such function may play a determinant role in disease progression and response to highly active antiretroviral therapy (HAART). These studies suggest that the thymus is functional in many adults with HIV disease and that thymic function might be induced as a consequence of HIV-mediated peripheral T cell depletion. Growth hormone is a potent regulator of thymic function. This study will determine whether true thymic function can be induced in HIV infected adults, whether such induction is indeed prompted by growth hormone, and whether thymic function plays a role in sustaining the T cell compartment in the face of peripheral T cell depletion.

Twenty-four volunteers will be enrolled in this 2 year study. All participants will receive 12 months of treatment with human growth hormone. Participants will be randomly assigned to one of two study arms. Twelve participants (Arm 1) will receive growth hormone during the first year of the study (3 mg given daily by subcutaneous injection, with dose reduction to 1.5 mg after 6 months). Twelve participants (Arm 2) will be enrolled in an observational control arm (no placebo injections) that will cross over to growth hormone treatment after 1 year. Participants, whether in Arm 1 or Arm 2, will have as many as 24 scheduled study visits during the 2 years after enrollment. In general, study visits occur every every 1 to 3 months. Study visits will include physical exams, blood tests, CT scans, PET scans, and DEXA scans.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94141
        • Gladstone Institute of Virology and Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Growth Hormone Arm
Growth hormone receipt in the first year, post-growth hormone follow-up in the second year
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
Other Names:
  • Serostim
Active Comparator: 2
Observation only in the 1st year, GH receipt in the second year
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
Other Names:
  • Serostim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of 1 year of growth hormone treatment on thymus mass, naive and total T cells
Time Frame: Thymus mass- months 0,6,12; Naive and total T cells - months 1,3,6,9,12
Thymus mass- months 0,6,12; Naive and total T cells - months 1,3,6,9,12
TREC content in circulating lymphocytes
Time Frame: Months 0,1,3,6,9,12
Months 0,1,3,6,9,12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: T cell repertoire Months 0,6,12, all others Months 0,1,3,6,9,12
T cell repertoire Months 0,6,12, all others Months 0,1,3,6,9,12
metabolic activity of thymus
Time Frame: Months 0, 12
Months 0, 12
body composition
Time Frame: Months 0,3,6,12
Months 0,3,6,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

EMD Serono
University of California, San Francisco
National Center for Research Resources (NCRR)
The J. David Gladstone Institutes

Investigators

  • Principal Investigator: Laura A. Napolitano, MD, University of California, San Francisco
  • Principal Investigator: Joseph M. McCune, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 16, 2003

First Submitted That Met QC Criteria

October 16, 2003

First Posted (Estimate)

October 17, 2003

Study Record Updates

Last Update Posted (Estimate)

August 17, 2009

Last Update Submitted That Met QC Criteria

August 14, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AI043864 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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