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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287677
• Other study ID #: VIHCREC01
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2006
• Last updated: November 3, 2009
• Start date: January 2006
• Est. completion date: July 2009

Study information

• Verified date: November 2009
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• recombinant human Growth Hormone
Growth Hormone during 6 months (30UG/KG/DAY)
• Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

Drug:
• HAART
HAART all over the trial

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Carlos III Health Institute, Hospital Clinic of Barcelona, Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The rhGH activates the thymic function.		from one year post rhGH administration	Yes
Secondary	This effect is lasting once the rhGH administration is interrupted.		from at least one year since the last rhGH administration	Yes