Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119769
Status:
COMPLETED
Last Update Posted:
2008-08-27
First Post:
2005-07-07
Brief Title:
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy HAART
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 07 mg genotropin demonstrating an immune stimulating effect as well as an increased limb fattruncal 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
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 07 mg genotropin demonstrating an immune stimulating effect as well as an increased limb fattruncal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None