A Phase 4 interventional study of Placebo and Genotropin (human recombinant Growth hormone) in HIV Infections and Lipodystrophy, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to male participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-08-27.
Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Treatment
The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
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.
163 studies on the registry are indexed under Lipodystrophy; 11 are open to participants now.
This study's enrollment of 46 is close to the median of 46 across 119 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Drug: Placebo
Drug: Genotropin (human recombinant Growth hormone)
Placebo, 0.7 mg/day injected subcutaneously
Genotropin, 0.7 mg/day injected subcutaneously
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
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
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Hvidovre University Hospital