The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
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ClinicalTrials.gov Identifier: NCT00119769 |
Recruitment Status
:
Completed
First Posted
: July 14, 2005
Last Update Posted
: August 27, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Lipodystrophy | Drug: Placebo Drug: Genotropin (human recombinant Growth hormone) | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART) |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Drug: Placebo
Placebo, 0.7 mg/day injected subcutaneously
|
Active Comparator: 2 |
Drug: Genotropin (human recombinant Growth hormone)
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 ]

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male
- Caucasian race
- Age >21 years, <60 years
- HIV-1 infection
- HAART treated > 12 months
- HIV-RNA < 100 copies/ml
- CD4 count > 200
- Fasting plasma glucose < 6.1 mM
- Stable weight
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119769
Denmark | |
Clinical Research Unit, Hvidovre University Hospital | |
Hvidovre, Denmark, 2650 |
Principal Investigator: | Birgitte R Hansen, MD |
Publications:
Responsible Party: | Ove Andersen, Clinical Research Center, Copenhagen University Hospital Hvidovre, Denmark |
ClinicalTrials.gov Identifier: | NCT00119769 History of Changes |
Other Study ID Numbers: |
KFE001 |
First Posted: | July 14, 2005 Key Record Dates |
Last Update Posted: | August 27, 2008 |
Last Verified: | August 2008 |
Keywords provided by Hvidovre University Hospital:
HIV immune stimulation lipodystrophy |
growth hormone recombinant growth hormone Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |