Status:
COMPLETED
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Conditions:
HIV Infections
Eligibility:
All Genders
25-50 years
Phase:
PHASE4
Brief 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 ma...
Detailed Description
The purpose of a therapeutic vaccine is to control, induce and expand humoral and cellular immune responses capable to control HIV infection. The administration of a conventional vaccine results in th...
Eligibility Criteria
Inclusion
- HIV-1 asymptomatic patients in HAART regimen (\> 6 months)
- Viral load \< 50 copies/ml
- Number CD4 cells \> 250 cells/mm3
- Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)
- Well-disposition to rhGh daily administration (6 months of treatment)
Exclusion
- AIDS outbreak
- Allergy or hyperreactivity to rhGH or vaccines
- Diabetes Mellitus
- Renal, hepatic, pancreatic disorders
- Chronic diseases
- Dementia
- Pregnancy
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00287677
Start Date
January 1 2006
End Date
July 1 2009
Last Update
November 4 2009
Active Locations (2)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital Clinic de Barcelona
Barcelona, Spain, 08036