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

November 3, 2009 updated by: Germans Trias i Pujol Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Germans Trias I Pujol Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: from 24 weeks post rhGH administration
from 24 weeks post rhGH administration

Secondary Outcome Measures

Outcome Measure
Time Frame
The rhGH activates the thymic function.
Time Frame: from one year post rhGH administration
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
from at least one year since the last rhGH administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Hospital General Universitario Gregorio Marañon
Hospital Clinic of Barcelona
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2009

Last Update Submitted That Met QC Criteria

November 3, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIHCREC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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