HIV InfectionsPhase 4NCT00119769
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
A Phase 4 study testing Genotropin (human recombinant Growth hormone) in people with HIV Infections and Lipodystrophy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men only
- Conditions the study is for
- HIV Infections, Lipodystrophy
- What is being tested?
- Genotropin (human recombinant Growth hormone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Jul 2008
- Phase
- Phase 4
- 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 21 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Caucasian race
- Age >21 years, <60 years
- HIV-1 infection
- HAART treated > 12 months
- HIV-RNA < 100 copies/ml
Show all 9Show fewer
- CD4 count > 200
- Fasting plasma glucose < 6.1 mM
- Stable weight
Who cannot join
- BMI > 28 kg/m2 and BMI < 18.5 kg/m2
- Wasting or AIDS defining disease
- Severe chronic diseases other than HIV
- Cancer, previous transplantation
- Previous AMI
- Diabetes
Show all 14Show fewer
- Hormonal substitution therapy
- Lipid lowering or antidiabetic therapy within 3 months
- Abuse of narcotics or alcohol
- Major psychiatric disorders
- Adverse reactions towards Genotropin
- Calcium-ion < 1.15 or > 1.35 mM
- D-vitamin < 19 nM
- TSH < 0.1 or > 10 mIU/l
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical Research Unit, Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)
The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
Read the detailed description
Following the introduction of highly active antiretroviral therapy (HAART) in the mid-nineties, the improvement in the clinical course of HIV has lead to a dramatic reduction in morbidity and mortality. However, a growing concern has been the emergence of an increasing number of drug therapy failure, mainly caused by rebounding virus. This effect in turn is prompted respectively by developing resistance and failing compliance mainly due to early or late adverse reactions. These adverse reactions mainly consists of a number of metabolic and morphologic changes, known as HIV associated lipodystrophy syndrome (HALS) and affects approximately 40 % of HIV infected patients on HAART. HALS is characterized by lipoatrophy on extremities, gluteal and facial regions combined with intraabdominal lipoaccumulation, "buffalo hump" and lipomas.
Thus, despite progress in the development of new drugs with new targets and resistance profiles the need for agents with immune modulating properties is evident, both as a way to overcome the problems of resistance and hopefully modify treatment regimens in order to reduce the exposure to late adverse reactions caused by HAART. A number of studies have addressed the problems of modulating the immune response during HIV infection. Results are promising but a major obstacle seems to be adverse effects. In the pre-HAART era high dose human growth hormone (hGH) therapy has been used for HIV wasting and in the HAART era the impact on fat distribution in HIV infected patients have been investigated based on the lipolytic properties of hGH. However high dosage of hGH has been associated with severe adverse effects limiting the usefulness in daily clinical practice. One recent study demonstrated increments in thymic mass and a rise in the number of circulating naïve CD4 T cells upon treatment with high dose hGH. Our group has conducted a 60 week pilot study with daily injection of 0.7 mg genotropin, demonstrating an immune stimulating effect as well as an increased limb fat/truncal fat ratio, without metabolic and clinically recognizable side effects. Based on these findings we plan to perform a randomized, double blind, prospective, interventional study including 50 HIV infected patients on HAART, investigating the effect of low dose hGH on immune status and fat distribution.
- Conditions
- HIV Infections, Lipodystrophy
- Being tested
- Placebo, Genotropin (human recombinant Growth hormone)
- Keywords
- HIV, immune stimulation, lipodystrophy, growth hormone, recombinant growth hormone, Treatment Experienced
- Medical subject headings
- HIV Infections, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, 0.7 mg/day injected subcutaneously
Genotropin (human recombinant Growth hormone)Drug
Genotropin, 0.7 mg/day injected subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: Genotropin (human recombinant Growth hormone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months
Measured: 9 months
Secondary outcomes (8)
Impact of hGH 0.7 mg/day at 9 months on thymic size
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on glucose metabolism i.e.glucose tolerance, insulin sensitivity and beta cell function as measured by OGTT
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on lipid profile
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on quality of life and adherence to HAART
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on cytokines
Measured: 9 months
Impact of hGH 0.7 mg/day at 9 months on safety parameters
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startFeb 2005
- Primary completionMay 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Birgitte R Hansen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119769
- Sponsor's protocol ID
- KFE001
- Status last verified
- Aug 2008
- First submitted
- 7 Jul 2005
- Last updated
- 27 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen O, Haugaard SB, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Different growth hormone sensitivity of target tissues and growth hormone response to glucose in HIV-infected patients with and without lipodystrophy. Scand J Infect Dis. 2004;36(11-12):832-9. doi: 10.1080/00365540410021162.
PubMed 15764170Haugaard SB, Andersen O, Dela F, Holst JJ, Storgaard H, Fenger M, Iversen J, Madsbad S. Defective glucose and lipid metabolism in human immunodeficiency virus-infected patients with lipodystrophy involve liver, muscle tissue and pancreatic beta-cells. Eur J Endocrinol. 2005 Jan;152(1):103-12. doi: 10.1530/eje.1.01835.
PubMed 15762193Haugaard SB, Andersen O, Volund A, Hansen BR, Iversen J, Andersen UB, Nielsen JO, Madsbad S. Beta-cell dysfunction and low insulin clearance in insulin-resistant human immunodeficiency virus (HIV)-infected patients with lipodystrophy. Clin Endocrinol (Oxf). 2005 Mar;62(3):354-61. doi: 10.1111/j.1365-2265.2005.02223.x.
PubMed 15730419Haugaard SB, Andersen O, Hansen BR, Andersen UB, Volund A, Iversen J, Nielsen JO, Madsbad S. In nondiabetic, human immunodeficiency virus-infected patients with lipodystrophy, hepatic insulin extraction and posthepatic insulin clearance rate are decreased in proportion to insulin resistance. Metabolism. 2005 Feb;54(2):171-9. doi: 10.1016/j.metabol.2004.08.009.
PubMed 15690310Haugaard SB, Andersen O, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Insulin-like growth factors, insulin-like growth factor-binding proteins, insulin-like growth factor-binding protein-3 protease, and growth hormone-binding protein in lipodystrophic human immunodeficiency virus-infected patients. Metabolism. 2004 Dec;53(12):1565-73. doi: 10.1016/j.metabol.2004.06.025.
PubMed 15562401Andersen O, Haugaard SB, Flyvbjerg A, Andersen UB, Orskov H, Madsbad S, Nielsen JO, Iversen J. Low-dose growth hormone and human immunodeficiency virus-associated lipodystrophy syndrome: a pilot study. Eur J Clin Invest. 2004 Aug;34(8):561-8. doi: 10.1111/j.1365-2362.2004.01380.x.
PubMed 15305891
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00119769
- Acronym / sponsor ID
- KFE001
- Conditions
- HIV Infections, Lipodystrophy
- Keywords
- HIV, immune stimulation, lipodystrophy, growth hormone, recombinant growth hormone, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Jul 2005 (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.
The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
Detailed description
Following the introduction of highly active antiretroviral therapy (HAART) in the mid-nineties, the improvement in the clinical course of HIV has lead to a dramatic reduction in morbidity and mortality. However, a growing concern has been the emergence of an increasing number of drug therapy failure, mainly caused by rebounding virus. This effect in turn is prompted respectively by developing resistance and failing compliance mainly due to early or late adverse reactions. These adverse reactions mainly consists of a number of metabolic and morphologic changes, known as HIV associated lipodystrophy syndrome (HALS) and affects approximately 40 % of HIV infected patients on HAART. HALS is characterized by lipoatrophy on extremities, gluteal and facial regions combined with intraabdominal lipoaccumulation, "buffalo hump" and lipomas.
Thus, despite progress in the development of new drugs with new targets and resistance profiles the need for agents with immune modulating properties is evident, both as a way to overcome the problems of resistance and hopefully modify treatment regimens in order to reduce the exposure to late adverse reactions caused by HAART. A number of studies have addressed the problems of modulating the immune response during HIV infection. Results are promising but a major obstacle seems to be adverse effects. In the pre-HAART era high dose human growth hormone (hGH) therapy has been used for HIV wasting and in the HAART era the impact on fat distribution in HIV infected patients have been investigated based on the lipolytic properties of hGH. However high dosage of hGH has been associated with severe adverse effects limiting the usefulness in daily clinical practice. One recent study demonstrated increments in thymic mass and a rise in the number of circulating naïve CD4 T cells upon treatment with high dose hGH. Our group has conducted a 60 week pilot study with daily injection of 0.7 mg genotropin, demonstrating an immune stimulating effect as well as an increased limb fat/truncal fat ratio, without metabolic and clinically recognizable side effects. Based on these findings we plan to perform a randomized, double blind, prospective, interventional study including 50 HIV infected patients on HAART, investigating the effect of low dose hGH on immune status and fat distribution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: Genotropin (human recombinant Growth hormone) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male
- Caucasian race
- Age >21 years, <60 years
- HIV-1 infection
- HAART treated > 12 months
Key exclusion criteria (14 listed)
- BMI > 28 kg/m2 and BMI < 18.5 kg/m2
- Wasting or AIDS defining disease
- Severe chronic diseases other than HIV
- Cancer, previous transplantation
- Previous AMI
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 |
|---|---|---|
| PlaceboPlacebo, 0.7 mg/day injected subcutaneously | Drug | 1 |
| Genotropin (human recombinant Growth hormone)Genotropin, 0.7 mg/day injected subcutaneously | Drug | 2 |
Primary outcome
Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months
Time frame: 9 months
8 secondary outcomes
Impact of hGH 0.7 mg/day at 9 months on thymic size
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on glucose metabolism i.e.glucose tolerance, insulin sensitivity and beta cell function as measured by OGTT
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on lipid profile
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on quality of life and adherence to HAART
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on cytokines
Time frame: 9 months
Impact of hGH 0.7 mg/day at 9 months on safety parameters
Time frame: 9 months
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 27 Aug 2008.
- Background: PubMed 15764170Andersen O, Haugaard SB, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Different growth hormone sensitivity of target tissues and growth hormone response to glucose in HIV-infected patients with and without lipodystrophy. Scand J Infect Dis. 2004;36(11-12):832-9. doi: 10.1080/00365540410021162.
- Background: PubMed 15762193Haugaard SB, Andersen O, Dela F, Holst JJ, Storgaard H, Fenger M, Iversen J, Madsbad S. Defective glucose and lipid metabolism in human immunodeficiency virus-infected patients with lipodystrophy involve liver, muscle tissue and pancreatic beta-cells. Eur J Endocrinol. 2005 Jan;152(1):103-12. doi: 10.1530/eje.1.01835.
- Background: PubMed 15730419Haugaard SB, Andersen O, Volund A, Hansen BR, Iversen J, Andersen UB, Nielsen JO, Madsbad S. Beta-cell dysfunction and low insulin clearance in insulin-resistant human immunodeficiency virus (HIV)-infected patients with lipodystrophy. Clin Endocrinol (Oxf). 2005 Mar;62(3):354-61. doi: 10.1111/j.1365-2265.2005.02223.x.
- Background: PubMed 15690310Haugaard SB, Andersen O, Hansen BR, Andersen UB, Volund A, Iversen J, Nielsen JO, Madsbad S. In nondiabetic, human immunodeficiency virus-infected patients with lipodystrophy, hepatic insulin extraction and posthepatic insulin clearance rate are decreased in proportion to insulin resistance. Metabolism. 2005 Feb;54(2):171-9. doi: 10.1016/j.metabol.2004.08.009.
- Background: PubMed 15562401Haugaard SB, Andersen O, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Insulin-like growth factors, insulin-like growth factor-binding proteins, insulin-like growth factor-binding protein-3 protease, and growth hormone-binding protein in lipodystrophic human immunodeficiency virus-infected patients. Metabolism. 2004 Dec;53(12):1565-73. doi: 10.1016/j.metabol.2004.06.025.
- Background: PubMed 15305891Andersen O, Haugaard SB, Flyvbjerg A, Andersen UB, Orskov H, Madsbad S, Nielsen JO, Iversen J. Low-dose growth hormone and human immunodeficiency virus-associated lipodystrophy syndrome: a pilot study. Eur J Clin Invest. 2004 Aug;34(8):561-8. doi: 10.1111/j.1365-2362.2004.01380.x.
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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.
Birgitte R Hansen, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genotropin (human recombinant Growth hormone) in people with HIV Infections and Lipodystrophy, run by Hvidovre University Hospital at 1 site in Denmark.
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 9 inclusion and 14 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 27 Aug 2008. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months (time frame: 9 months). 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 NCT00119769, which also lists 6 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 27 Aug 2008.