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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: recombinant human Growth Hormone Biological: Vaccination Drug: HAART Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients
Study Start Date : January 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
growth hormone + vaccination + HAART
 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: B
growth hormone + HAART
 Biological: recombinant human Growth Hormone
Growth Hormone during 6 months (30UG/KG/DAY)

Drug: HAART
HAART all over the trial
Experimental: C
vaccination + HAART
 Biological: Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

Drug: HAART
HAART all over the trial
Active Comparator: D
control healthy HIV negative + vaccination
 Biological: Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The rhGH activates the thymic function. [ Time Frame: from one year post rhGH administration ]
  2. This effect is lasting once the rhGH administration is interrupted. [ Time Frame: from at least one year since the last rhGH administration ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287677


Locations
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Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Carlos III Health Institute
Investigators
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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
More Information
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Responsible Party: Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT00287677    
Other Study ID Numbers: VIHCREC01
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: November 4, 2009
Last Verified: November 2009
Keywords provided by Germans Trias i Pujol Hospital:
Growth Hormone
HIV-1
Vaccination
 Thymopoiesis
HIV-specific responses
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs