Clinical Trials
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
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
NCT00287677
First received: February 6, 2006
Last updated: November 3, 2009
Last Verified: November 2009
History of Changes
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 ]
- 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.
EligibilityEligibility
Ages Eligible for Study: | 25 Years to 50 Years | |
Sexes Eligible for Study: | All | |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- HIV-1 asymptomatic patients in HAART regimen (> 6 months)
- Viral load < 50 copies/ml
- Number CD4 cells > 250 cells/mm3
- Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)
- Well-disposition to rhGh daily administration (6 months of treatment)
Exclusion Criteria:
- AIDS outbreak
- Allergy or hyperreactivity to rhGH or vaccines
- Diabetes Mellitus
- Renal, hepatic, pancreatic disorders
- Chronic diseases
- Dementia
- 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 Show More
Spain | ||
Germans Trias i Pujol Hospital | ||
Badalona, Barcelona, Spain, 08916 | ||
Hospital Clinic de Barcelona | ||
Barcelona, Spain, 08036 | ||
Sponsors and Collaborators
Germans Trias i Pujol HospitalHospital 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
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 HormoneHIV-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.