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

Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287677

Enrollment

Registered

2006-02-07

Start date

2006-01-31

Completion date

2009-07-31

Last updated

2009-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Growth Hormone, HIV-1, Vaccination, Thymopoiesis, HIV-specific responses, Treatment Experienced

Brief summary

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.

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.

Interventions

BIOLOGICALrecombinant human Growth Hormone

Growth Hormone during 6 months (30UG/KG/DAY)

BIOLOGICALVaccination

Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

DRUGHAART

HAART all over the trial

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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).	from 24 weeks post rhGH administration

Secondary

Measure	Time frame
The rhGH activates the thymic function.	from one year post rhGH administration
This effect is lasting once the rhGH administration is interrupted.	from at least one year since the last rhGH administration

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026