The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients

NCT00119769

Last updated date
Study Location
Clinical Research Unit, Hvidovre University Hospital
Hvidovre, , 2650, Denmark
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections, Lipodystrophy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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HIV Infections, LipodystrophyThe Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
NCT00119769
  1. Hvidovre,
Male
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
Official Title  ICMJE The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Lipodystrophy
Intervention  ICMJE
  • Drug: Placebo
    Placebo, 0.7 mg/day injected subcutaneously
  • Drug: Genotropin (human recombinant Growth hormone)
    Genotropin, 0.7 mg/day injected subcutaneously
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Intervention: Drug: Genotropin (human recombinant Growth hormone)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2008)
46
Original Enrollment  ICMJE
 (submitted: July 7, 2005)
50
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00119769
Other Study ID Numbers  ICMJE KFE001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ove Andersen, Clinical Research Center, Copenhagen University Hospital Hvidovre, Denmark
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Birgitte R Hansen, MD
PRS Account Hvidovre University Hospital
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP