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

Tracking Information
First Submitted Date ICMJE	February 6, 2006
First Posted Date ICMJE	February 7, 2006
Last Update Posted Date	November 4, 2009
Study Start Date ICMJE	January 2006
Actual Primary Completion Date	July 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 14, 2007)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: February 6, 2006)	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; (submitted: November 14, 2007)	The rhGH activates the thymic function. [ Time Frame: 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 ]
Original Secondary Outcome Measures ICMJE; (submitted: February 6, 2006)	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; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: May 7, 2009)	33
Original Enrollment ICMJE; (submitted: February 6, 2006)	46
Actual Study Completion Date	July 2009
Actual 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
Sex/Gender	Sexes Eligible for Study: All
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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