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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Page 1 of 1 (2 locations)

1

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain, 08916

2

Hospital Clinic de Barcelona

Barcelona, Spain, 08036