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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 |
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Information provided by: | Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00287677 |
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 |
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HIV Infections |
Biological: recombinant human Growth Hormone Biological: Vaccination Drug: HAART |
Phase IV |
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 |
Enrollment: | 33 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
growth hormone + vaccination + HAART
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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
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B: Experimental
growth hormone + HAART
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Biological: recombinant human Growth Hormone
Growth Hormone during 6 months (30UG/KG/DAY)
Drug: HAART
HAART all over the trial
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C: Experimental
vaccination + HAART
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Biological: Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16
Drug: HAART
HAART all over the trial
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D: Active Comparator
control healthy HIV negative + vaccination
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Biological: Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16
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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.
Ages Eligible for Study: | 25 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital Clinic de Barcelona | |
Barcelona, Spain, 08036 | |
Spain, Barcelona | |
Germans Trias i Pujol Hospital | |
Badalona, Barcelona, Spain, 08916 |
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 |
Responsible Party: | Germans Trias i Pujol Hospital ( Germans Trias i Pujol Hospital ) |
Study ID Numbers: | VIHCREC01 |
Study First Received: | February 6, 2006 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00287677 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Growth Hormone HIV-1 Vaccination |
Thymopoiesis HIV-specific responses Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Hormone Antagonists Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Hormones, Hormone Substitutes, and Hormone Antagonists Infection |
Hormones Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |