NCT00287677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jan 2006

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 4, 2009

Status Verified

November 1, 2009

Enrollment Period

3.5 years

First QC Date

February 6, 2006

Last Update Submit

November 3, 2009

Conditions

HIV Infections

Keywords

Growth HormoneHIV-1VaccinationThymopoiesisHIV-specific responsesTreatment Experienced

Outcome Measures

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).

    from 24 weeks post rhGH administration

Secondary Outcomes (2)

  • 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

Study Arms (4)

A

EXPERIMENTAL

growth hormone + vaccination + HAART

Biological: recombinant human Growth HormoneBiological: VaccinationDrug: HAART

B

EXPERIMENTAL

growth hormone + HAART

Biological: recombinant human Growth HormoneDrug: HAART

C

EXPERIMENTAL

vaccination + HAART

Biological: VaccinationDrug: HAART

D

ACTIVE COMPARATOR

control healthy HIV negative + vaccination

Biological: Vaccination

Interventions

recombinant human Growth HormoneBIOLOGICAL

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

AB
VaccinationBIOLOGICAL

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

ACD
HAARTDRUG

HAART all over the trial

ABC

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • AIDS outbreak
  • Allergy or hyperreactivity to rhGH or vaccines
  • Diabetes Mellitus
  • Renal, hepatic, pancreatic disorders
  • Chronic diseases
  • Dementia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Growth HormoneVaccinationAntiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsImmunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public HealthDrug Therapy, CombinationDrug Therapy

Study Officials

  • Bonaventura Clotet, PhD

    IrsiCaixa Foundation-Germans Trias i Pujol Hospital

    STUDY DIRECTOR

  • Lidia Ruiz, PhD

    Irsicaixa Foundation-Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

  • Jose Mª Gatell, PhD

    Hospital Clinic of Barcelona

    STUDY DIRECTOR

  • Margarita Bofill, PhD

    Irsicaixa Foundation- Germans Trias i Pujol Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

January 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 4, 2009

Record last verified: 2009-11

Locations

ES(2)