HIV InfectionsPhase 4NCT00287677
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
A Phase 4 study testing recombinant human Growth Hormone, Vaccination and HAART in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- recombinant human Growth Hormone, Vaccination and HAART
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2006to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- AIDS outbreak
- Allergy or hyperreactivity to rhGH or vaccines
- Diabetes Mellitus
- Renal, hepatic, pancreatic disorders
- Chronic diseases
- Dementia
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital Clinic de Barcelona
Barcelona, 08036
About this study
Official title: Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- recombinant human Growth Hormone, Vaccination, HAART
- Keywords
- Growth Hormone, HIV-1, Vaccination, Thymopoiesis, HIV-specific responses, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human Growth HormoneBiological
Growth Hormone during 6 months (30UG/KG/DAY)
VaccinationBiological
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16
HAARTDrug
HAART all over the trial
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | growth hormone + vaccination + HAART Receives: Biological: recombinant human Growth Hormone; Biological: Vaccination; Drug: HAART |
| B | Experimental | growth hormone + HAART Receives: Biological: recombinant human Growth Hormone; Drug: HAART |
| C | Experimental | vaccination + HAART Receives: Biological: Vaccination; Drug: HAART |
| D | Active comparator | control healthy HIV negative + vaccination Receives: Biological: Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from 24 weeks post rhGH administration
Secondary outcomes (2)
The rhGH activates the thymic function.
Measured: from one year post rhGH administration
This effect is lasting once the rhGH administration is interrupted.
Measured: from at least one year since the last rhGH administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital General Universitario Gregorio Marañon, Carlos III Health Institute
- Investigators
- Bonaventura Clotet, PhD, Study director, IrsiCaixa Foundation-Germans Trias i Pujol HospitalLidia Ruiz, PhD, Principal investigator, Irsicaixa Foundation-Germans Trias i Pujol HospitalJose Mª Gatell, PhD, Study director, Hospital Clinic of BarcelonaMargarita Bofill, PhD, Study director, Irsicaixa Foundation- Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287677
- Sponsor's protocol ID
- VIHCREC01
- Status last verified
- Nov 2009
- First submitted
- 6 Feb 2006
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00287677
- Acronym / sponsor ID
- VIHCREC01
- Conditions
- HIV Infections
- Keywords
- Growth Hormone, HIV-1, Vaccination, Thymopoiesis, HIV-specific responses, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital General Universitario Gregorio Marañon, Carlos III Health Institute
- Study start
- Jan 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: recombinant human Growth Hormone, Biological: Vaccination, Drug: HAARTgrowth hormone + vaccination + HAART |
| B | Experimental | Biological: recombinant human Growth Hormone, Drug: HAARTgrowth hormone + HAART |
| C | Experimental | Biological: Vaccination, Drug: HAARTvaccination + HAART |
| D | Active comparator | Biological: Vaccinationcontrol healthy HIV negative + vaccination |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- AIDS outbreak
- Allergy or hyperreactivity to rhGH or vaccines
- Diabetes Mellitus
- Renal, hepatic, pancreatic disorders
- Chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human Growth HormoneGrowth Hormone during 6 months (30UG/KG/DAY) | Biological | A, B |
| VaccinationVaccination (Hepatitis A+B + tetanus toxoid) at week 16 | Biological | A, C, D |
| HAARTHAART all over the trial | Drug | A, B, C |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonaventura Clotet, PhD study director
IrsiCaixa Foundation-Germans Trias i Pujol Hospital
Lidia Ruiz, PhD principal investigator
Irsicaixa Foundation-Germans Trias i Pujol Hospital
Jose Mª Gatell, PhD study director
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant human Growth Hormone, Vaccination and HAART in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2009.