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NCT Number: NCT00287677

Induction and Expansion of T Cell Repertoire Using 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.

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant human Growth Hormone

Biological

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

Vaccination

Biological

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

HAART

Drug

HAART all over the trial

Primary outcomes

  1. 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

Secondary outcomes

  1. The rhGH activates the thymic function.

    Time frame: from one year post rhGH administration

  2. This effect is lasting once the rhGH administration is interrupted.

    Time frame: from at least one year since the last rhGH administration

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Carlos III Health Institute
  • Hospital Clinic of Barcelona
  • Hospital General Universitario Gregorio Marañon

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 7, 2006
Registry last updated
Nov 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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