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

This study has been completed.

Sponsor:

Collaborators:

Hospital Clinic of Barcelona

Hospital General Universitario Gregorio Marañon

Carlos III Health Institute

Information provided by:

Germans Trias i Pujol Hospital

ClinicalTrials.gov Identifier:

NCT00287677

First received: February 6, 2006

Last updated: November 3, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2006

Last Updated Date

November 3, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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).

Change History

Complete list of historical versions of study NCT00287677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The rhGH activates the thymic function. [ Time Frame: from one year post rhGH administration ] [ Designated as safety issue: Yes ]
This effect is lasting once the rhGH administration is interrupted. [ Time Frame: from at least one year since the last rhGH administration ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The rhGH activates the thymic function.
The effect of the rhGh can be expanded by vaccine immunization.
This effect is lasting once the rhGH administration is interrupted.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
growth hormone + vaccination + HAART
Interventions:
- Biological: recombinant human Growth Hormone
- Biological: Vaccination
- Drug: HAART
Experimental: B
growth hormone + HAART
Interventions:
- Biological: recombinant human Growth Hormone
- Drug: HAART
Experimental: C
vaccination + HAART
Interventions:
- Biological: Vaccination
- Drug: HAART
Active Comparator: D
control healthy HIV negative + vaccination

Intervention: Biological: Vaccination

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 50 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00287677

Other Study ID Numbers ^ICMJE

VIHCREC01

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Germans Trias i Pujol Hospital

Study Sponsor ^ICMJE

Germans Trias i Pujol Hospital

Collaborators ^ICMJE

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

Investigators ^ICMJE

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

Information Provided By

Germans Trias i Pujol Hospital

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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