Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion of immune reconstitution and broaden specific T cell responses not achievable by vaccination alone. The main objective of that study is to test the validity of this hypothesis with vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the near future. This is a pilot, randomized, clinical open label study aimed to investigate thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1 infected patients in highly active antiretroviral therapy (HAART) regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Carlos III Health Institute; Hospital Clinic of Barcelona; Hospital General Universitario Gregorio Marañon
• Treatments: Hormones; Vaccines

Criteria

Inclusion Criteria:

1. HIV-1 asymptomatic patients in HAART regimen (> 6 months)

2. Viral load < 50 copies/ml

3. Number CD4 cells > 250 cells/mm3

4. Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)

5. Well-disposition to rhGh daily administration (6 months of treatment)

Exclusion Criteria:

1. AIDS outbreak

2. Allergy or hyperreactivity to rhGH or vaccines

3. Diabetes Mellitus

4. Renal, hepatic, pancreatic disorders

5. Chronic diseases

6. Dementia

7. Pregnancy