The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv-infections
Started Feb 2005
Typical duration for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 7, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedAugust 27, 2008
August 1, 2008
2.2 years
July 7, 2005
August 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months
9 months
Secondary Outcomes (8)
Impact of hGH 0.7 mg/day at 9 months on thymic size
9 months
Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans
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
9 months
Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp
9 months
Impact of hGH 0.7 mg/day at 9 months on lipid profile
9 months
- +3 more secondary outcomes
Study Arms (2)
1
PLACEBO COMPARATOR2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- Pfizercollaborator
Study Sites (1)
Clinical Research Unit, Hvidovre University Hospital
Hvidovre, 2650, Denmark
Related Publications (6)
Andersen O, Haugaard SB, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Different growth hormone sensitivity of target tissues and growth hormone response to glucose in HIV-infected patients with and without lipodystrophy. Scand J Infect Dis. 2004;36(11-12):832-9. doi: 10.1080/00365540410021162.
PMID: 15764170BACKGROUNDHaugaard SB, Andersen O, Dela F, Holst JJ, Storgaard H, Fenger M, Iversen J, Madsbad S. Defective glucose and lipid metabolism in human immunodeficiency virus-infected patients with lipodystrophy involve liver, muscle tissue and pancreatic beta-cells. Eur J Endocrinol. 2005 Jan;152(1):103-12. doi: 10.1530/eje.1.01835.
PMID: 15762193BACKGROUNDHaugaard SB, Andersen O, Volund A, Hansen BR, Iversen J, Andersen UB, Nielsen JO, Madsbad S. Beta-cell dysfunction and low insulin clearance in insulin-resistant human immunodeficiency virus (HIV)-infected patients with lipodystrophy. Clin Endocrinol (Oxf). 2005 Mar;62(3):354-61. doi: 10.1111/j.1365-2265.2005.02223.x.
PMID: 15730419BACKGROUNDHaugaard SB, Andersen O, Hansen BR, Andersen UB, Volund A, Iversen J, Nielsen JO, Madsbad S. In nondiabetic, human immunodeficiency virus-infected patients with lipodystrophy, hepatic insulin extraction and posthepatic insulin clearance rate are decreased in proportion to insulin resistance. Metabolism. 2005 Feb;54(2):171-9. doi: 10.1016/j.metabol.2004.08.009.
PMID: 15690310BACKGROUNDHaugaard SB, Andersen O, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Insulin-like growth factors, insulin-like growth factor-binding proteins, insulin-like growth factor-binding protein-3 protease, and growth hormone-binding protein in lipodystrophic human immunodeficiency virus-infected patients. Metabolism. 2004 Dec;53(12):1565-73. doi: 10.1016/j.metabol.2004.06.025.
PMID: 15562401BACKGROUNDAndersen O, Haugaard SB, Flyvbjerg A, Andersen UB, Orskov H, Madsbad S, Nielsen JO, Iversen J. Low-dose growth hormone and human immunodeficiency virus-associated lipodystrophy syndrome: a pilot study. Eur J Clin Invest. 2004 Aug;34(8):561-8. doi: 10.1111/j.1365-2362.2004.01380.x.
PMID: 15305891BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Birgitte R Hansen, MD
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2005
First Posted
July 14, 2005
Study Start
February 1, 2005
Primary Completion
May 1, 2007
Study Completion
July 1, 2008
Last Updated
August 27, 2008
Record last verified: 2008-08