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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00119769
• Date of registration: 07/07/2005
• Prospective Registration: No
• Primary sponsor: Hvidovre University Hospital
• Public title: The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
• Scientific title: The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)
• Date of first enrolment: February 2005
• Target sample size: 46
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00119769
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Birgitte R Hansen, MD

Key inclusion & exclusion criteria

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



Age minimum: 21 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV Infections

Lipodystrophy

Intervention(s)

Drug: Placebo

Drug: Genotropin (human recombinant Growth hormone)

Primary Outcome(s)

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]

Secondary Outcome(s)

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 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 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 safety parameters [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 thymic size [Time Frame: 9 months]

Secondary ID(s)

KFE001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer