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

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ClinicalTrials.gov Identifier: NCT00287677
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : November 4, 2009
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Carlos III Health Institute
Information provided by:
Germans Trias i Pujol Hospital

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 7, 2006
Last Update Posted Date November 4, 2009
Study Start Date  ICMJE January 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
  • The rhGH activates the thymic function. [ Time Frame: from one year post rhGH administration ]
  • This effect is lasting once the rhGH administration is interrupted. [ Time Frame: from at least one year since the last rhGH administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
Official Title  ICMJE Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients
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 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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2009)
33
Original Enrollment  ICMJE
 (submitted: February 6, 2006)
46
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287677
Other Study ID Numbers  ICMJE VIHCREC01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Germans Trias i Pujol Hospital
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Germans Trias i Pujol Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hospital Clinic of Barcelona
  • Hospital General Universitario Gregorio Marañon
  • Carlos III Health Institute
Investigators  ICMJE
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 of Barcelona
Study Director: Margarita Bofill, PhD Irsicaixa Foundation- Germans Trias i Pujol Hospital
PRS Account Germans Trias i Pujol Hospital
Verification Date November 2009

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