The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
Condition: HIV Infections; Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Interventional
Phase: Phase 4

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 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.
    

Intervention name(s): Placebo; Genotropin (human recombinant Growth hormone)
Intervention type(s): Drug; Drug
Intervention description(s): Placebo, 0.7 mg/day injected subcutaneously; Genotropin, 0.7 mg/day injected subcutaneously
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; immune stimulation; lipodystrophy; growth hormone; recombinant growth hormone; Treatment Experienced