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
  Purpose

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 Intervention Phase
HIV Infections
Biological: recombinant human Growth Hormone
Biological: Vaccination
Drug: HAART
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: January 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287677

Locations
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
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
  More Information

No publications provided

Responsible Party: Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT00287677     History of Changes
Other Study ID Numbers: VIHCREC01
Study First Received: February 6, 2006
Last Updated: November 3, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Germans Trias i Pujol Hospital:
Growth Hormone
HIV-1
Vaccination
Thymopoiesis
HIV-specific responses
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014