Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Germans Trias i Pujol Hospital

Collaborator
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Carlos III Health Institute

Information provided by (Responsible Party)
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier
NCT00287677

First received: February 6, 2006
Last updated: November 3, 2009
Last Verified: November 2009
History of Changes
Purpose

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
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

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 ]
Secondary Outcome Measures:
  • 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 ]

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

Eligibility

Ages Eligible for Study: 25 Years to 50 Years  
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

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 of Barcelona
Study Director: Margarita Bofill, PhD Irsicaixa Foundation- Germans Trias i Pujol Hospital
More Information

More Information


Responsible Party: Germans Trias i Pujol Hospital, 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  

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
Hormones
Vaccines

ClinicalTrials.gov processed this data on December 13, 2019
This information is provided by ClinicalTrials.gov.