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

NCT00287677 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2009-11-04

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Bonaventura Clotet, PhD · IrsiCaixa Foundation-Germans Trias i Pujol Hospital

  • Lidia Ruiz, PhD · Irsicaixa Foundation-Germans Trias i Pujol Hospital

  • Jose Mª Gatell, PhD · Hospital Clinic of Barcelona

  • Margarita Bofill, PhD · Irsicaixa Foundation- Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287677 on ClinicalTrials.gov