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| 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 |
| 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 |
| 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
|
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B: Experimental
GROWTH HORMONE + VACCINATION
|
Biological: recombinant human Growth Hormone
GROWTH HORMONE DURING 6 MONTHS (30UG/KG/DAY); HAART ALL OVER THE TRIAL
|
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C: Experimental
VACCINATION + HAART
|
Biological: VACCINATION
VACCINATION (HEPATITIS A+B + TETANUS TOXOID) AT WEEK16; HAART ALL OVER THE TRIAL
|
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D: Active Comparator
CONTROL HEALTHY HIV NEGATIVE + VACCINATION
|
Biological: VACCINATION
VACCINATION (HEPATITIS A+B + TETANUS TOXOID) AT WEEK 16
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Laila Darwich, PhD | +34 93 465 6374 ext 123 | ldarwich@irsicaixa.es |
| 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 | |||||
| Germans Trias i Pujol Hospital |
| Hospital Clinic of Barcelona |
| Hospital General Universitario Gregorio Marañon |
| Carlos III Health Institute |
| 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 |
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