HIV InfectionsPhase 2NCT00071240
Growth Hormone to Increase Immune Function in People With HIV
A Phase 2 study testing Somatropin (recombinant human growth hormone) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Somatropin (recombinant human growth hormone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Gladstone Institute of Virology and Immunology
San Francisco, California, 94141
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Somatropin (recombinant human growth hormone)
- Keywords
- Growth Hormone, HIV, AIDS, Thymus, CD4 Cell, Immune System, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin (recombinant human growth hormone)Drug
Also called Serostim
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
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone Arm | Experimental | Growth hormone receipt in the first year, post-growth hormone follow-up in the second year Receives: Drug: Somatropin (recombinant human growth hormone) |
| 2 | Active comparator | Observation only in the 1st year, GH receipt in the second year Receives: Drug: Somatropin (recombinant human growth hormone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 1 year of growth hormone treatment on thymus mass, naive and total T cells
Measured: Thymus mass- months 0,6,12; Naive and total T cells - months 1,3,6,9,12
TREC content in circulating lymphocytes
Measured: 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
Measured: T cell repertoire Months 0,6,12, all others Months 0,1,3,6,9,12
metabolic activity of thymus
Measured: Months 0, 12
body composition
Measured: Months 0,3,6,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2003 (estimated)
- Study startOct 2002
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- The J. David Gladstone Institutes, University of California, San Francisco, National Center for Research Resources (NCRR), EMD Serono
- Investigators
- Laura A. Napolitano, MD, Principal investigator, University of California, San FranciscoJoseph M. McCune, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071240
- Sponsor's protocol ID
- R01AI043864
- Other IDs
- R01AI043864
- Status last verified
- Aug 2009
- First submitted
- 16 Oct 2003
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12004268Napolitano 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.
PubMed 18292808Tesselaar 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.
PubMed 18292816
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Recombinant Growth Hormone to Enhance T-Cell Production in Adults Infected With HIV-1
- ClinicalTrials.gov ID
- NCT00071240
- Acronym / sponsor ID
- R01AI043864
- Conditions
- HIV Infections
- Keywords
- Growth Hormone, HIV, AIDS, Thymus, CD4 Cell, Immune System, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- The J. David Gladstone Institutes, University of California, San Francisco, National Center for Research Resources (NCRR), EMD Serono
- Study start
- Oct 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone Arm | Experimental | Drug: Somatropin (recombinant human growth hormone)Growth hormone receipt in the first year, post-growth hormone follow-up in the second year |
| 2 | Active comparator | Drug: Somatropin (recombinant human growth hormone)Observation only in the 1st year, GH receipt in the second year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin (recombinant human growth hormone)Also: Serostim3.0mg 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 | Drug | 2, Growth Hormone Arm |
Primary outcome
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
TREC content in circulating lymphocytes
Time frame: Months 0,1,3,6,9,12
3 secondary outcomes
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
metabolic activity of thymus
Time frame: Months 0, 12
body composition
Time frame: Months 0,3,6,12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
- Background: PubMed 12004268Napolitano 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.
- Results publication: PubMed 18292808Napolitano 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.
- Results publication: PubMed 18292816Tesselaar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A. Napolitano, MD principal investigator
University of California, San Francisco
Joseph M. McCune, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin (recombinant human growth hormone) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2009.