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

This study is currently recruiting participants.
Verified by Germans Trias i Pujol Hospital, November 2007

Sponsors and Collaborators: Germans Trias i Pujol Hospital
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
  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 HAART regimen.


Condition Intervention Phase
HIV Infections
Biological: recombinant human Growth Hormone
Biological: VACCINATION
Phase IV

MedlinePlus related topics:   AIDS    Hepatitis    Hepatitis A    Tetanus   

ChemIDplus related topics:   Tetanus Vaccine    Somatotropin    Somatropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 ]

Estimated Enrollment:   46
Study Start Date:   January 2006
Estimated Study Completion Date:   September 2008

Arms Assigned Interventions
A: Experimental
GROWTH HORMONE + VACCINATION + HAART
Biological: recombinant human Growth Hormone
GROWTH HORMONE DURING 6 MONTHS (30UG/kG/DAY); VACCINATION (HEPATITIS A+B +TETANUS TOXOID) AT WEEK 16; HAART ALL OVER THE TRIAL
B: Experimental
GROWTH HORMONE + VACCINATION
Biological: recombinant human Growth Hormone
GROWTH HORMONE DURING 6 MONTHS (30UG/KG/DAY); HAART ALL OVER THE TRIAL
C: Experimental
VACCINATION + HAART
Biological: VACCINATION
VACCINATION (HEPATITIS A+B + TETANUS TOXOID) AT WEEK16; HAART ALL OVER THE TRIAL
D: Active Comparator
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

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

Contacts
Contact: Laila Darwich, PhD     +34 93 465 6374 ext 123     ldarwich@irsicaixa.es    

Locations
Spain
Hospital Clinic de Barcelona     Recruiting
      Barcelona, Spain, 08036
      Principal Investigator: Felipe Garcia, MD            
      Sub-Investigator: Montserrat Plana, PhD            
Spain, Barcelona
Germans Trias i Pujol Hospital     Recruiting
      Badalona, Barcelona, Spain, 08916
      Principal Investigator: Laila Darwich, PhD            
      Sub-Investigator: Joan Romeu, MD            

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

Study ID Numbers:   VIHCREC01
First Received:   February 6, 2006
Last Updated:   November 14, 2007
ClinicalTrials.gov Identifier:   NCT00287677
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 04, 2008




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