Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Carlos III Health Institute
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00287677
First received: February 6, 2006
Last updated: November 3, 2009
Last verified: November 2009

February 6, 2006
November 3, 2009
January 2006
July 2009   (final data collection date for primary outcome measure)
Proportion of patients HIV+ that recover the immunospecific responses against tetanus toxoid and Hepatitis A at 24 weeks of rhGH administration (time of treatment interruption). [ Time Frame: from 24 weeks post rhGH administration ] [ Designated as safety issue: Yes ]
Proportion of patients HIV+ that recover the immunospecific responses against tetanus toxoid and Hepatitis A at 24 weeks of rhGH administration (time of treatment interruption).
Complete list of historical versions of study NCT00287677 on ClinicalTrials.gov Archive Site
  • The rhGH activates the thymic function. [ Time Frame: from one year post rhGH administration ] [ Designated as safety issue: Yes ]
  • This effect is lasting once the rhGH administration is interrupted. [ Time Frame: from at least one year since the last rhGH administration ] [ Designated as safety issue: Yes ]
  • The rhGH activates the thymic function.
  • The effect of the rhGh can be expanded by vaccine immunization.
  • This effect is lasting once the rhGH administration is interrupted.
Not Provided
Not Provided
 
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients

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.

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 the expansion of peripheral clones. Concomitant administration of rhGH may boost this expansion and reconstitute specific T cell responses not achievable by vaccination alone. In this study we want to investigate whether the administration of rhGH expand T cell repertoire and whether there is an increase in the specific cellular responses to HIV-1 and recall antigens and, lately, whether this responses can be further amplified after immunization with tetanus toxoid and hepatitis A vaccines. This Hypothesis will be evaluated by the measurement of thymic volume, the expansion of naïve, memory and effector cell subsets, analysis of thymic emigrants (TRECs) before, during and after rhGH administration and vaccination. Moreover, T cell receptor rearrangement, specific antibodies and cellular responses to antigenic peptides will be determined.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Biological: recombinant human Growth Hormone
    Growth Hormone during 6 months (30UG/KG/DAY)
  • Biological: Vaccination
    Vaccination (Hepatitis A+B + tetanus toxoid) at week 16
  • Drug: HAART
    HAART all over the trial
  • Experimental: A
    growth hormone + vaccination + HAART
    Interventions:
    • Biological: recombinant human Growth Hormone
    • Biological: Vaccination
    • Drug: HAART
  • Experimental: B
    growth hormone + HAART
    Interventions:
    • Biological: recombinant human Growth Hormone
    • Drug: HAART
  • Experimental: C
    vaccination + HAART
    Interventions:
    • Biological: Vaccination
    • Drug: HAART
  • Active Comparator: D
    control healthy HIV negative + vaccination
    Intervention: Biological: Vaccination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00287677
VIHCREC01
No
Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
  • Hospital Clinic of Barcelona
  • Hospital General Universitario Gregorio Marañon
  • Carlos III Health Institute
Study Director: Bonaventura Clotet, PhD IrsiCaixa Foundation-Germans Trias i Pujol Hospital
Principal Investigator: Lidia Ruiz, PhD Irsicaixa Foundation-Germans Trias i Pujol Hospital
Study Director: Jose Mª Gatell, PhD Hospital Clinic de Barcelona
Study Director: Margarita Bofill, PhD Irsicaixa Foundation- Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP