E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of the double strategy of administering Growth Hormone in combination with immunizations on the immune reconstitution and maintenance of the immune specific responses to tetanus toxin and hepatitis A, in non-symptomatic HIV-infected patients on antiretroviral suppressive treatment, who have not responded to a previous immunizations. |
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E.2.2 | Secondary objectives of the trial |
a-To evaluate if the Growth Hormone reactivates and/or induces the thymus function and, therefore, increases the T cell repertoire. The result of this expansion would have to induce the cellular responses capable to act against recall antigens and HIV.
b-To evaluate if this effect produced by the Growth Hormone could be expanded by immunizations (tetanus vaccine and hepatitis A) in patients who previously did not respond specifically to these antigens.
c-To evaluate if the cellular immune responses against tetanus toxin, hepatitis A and HIV obtained by the Growth Hormone are sustained after the interruption of Growth Hormone.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Functional degree by scale of Karnofsky ³ 80% 2. Age between 30 and 40 years old 3. The women in fertile age must have a negative test of pregnancy the 28 previous days before to the randomization and to practice a contraceptive method the study. 4, AST and ALT £5 times the superior limit of normality (LSN). 5, Bilirrubina £ 2 times LSN (the patients with Sd. de Gilbert or hiperbilirrubinemia induced by IPs must present bilirrubina < than 5 times LSN). 6, Amilasa <2.0 times LSN 7.Proteinuria < 2 g/L 8.Creatinina £1,5 veces LSN. 9.Granulocitari recount ³1000 cells/mm3 10.Hemoglobina ³9.5 g/dL. 11.Plaquets ³75,000/mm3 12.Glycemia without having eaten breakfast < 120 mg/dl. 13.Pacients HIV1 no-symptomatic in treatment with HAART in the last 6 months 14.Plasmatic undetectable viral load (<50 copys/mL) at the moment of the inclusion. 15.Plasmatic undetectable viral load (<400 copys/mL) during 1 year (four determinations) 16.CD4 between 250-500 cells/mm3 at the moment of the inclusion 17.CD4 nadir > 150 cells/mm3. 18. To have received the tetanus vaccine and hepatitis A and not presenting an answer to some of the corresponding antigens at the moment of the inclusion. 19. Not to have previously received HC, IL-2 or any immune modulator or immune stimulator. 20. Informed consent signed
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E.4 | Principal exclusion criteria |
1, Allergy or hypersensitivity to the HC or any of vaccines of the study. 2, Intolerance to the glucose (Glycemia in uninformed 120 mg/dl or 6.66 mmol/l). 3, Pancreatitis. 4, Syndrome of the carping tunnel, unless it has been solved surgically. 5, Isquemic cardio pathology 6. Any upheaval associated moderate edema or severe (Cirrhosis, nephritis, congestive insufficiency cardiac or lymphedema). 7, Active opportunistic infection definitive of AIDS in the 30 previous days to the inclusion. 8, Secondary prophylactic treatment of an opportunistic infection. 9. An active tumour except located cutaneous Kaposi Sarcoma and is not receiving active treatment. 10. A mass in SNC, or a process in SNC with active neurological findings. 11. Chronic Diarrhoea 12, Unstable or not treated hypertension. 13. No treated severe systemic infection, or suspect, persistent fever ³ 38,5ºC during the 30 previous days to the entrance in the study. 14. Evidence of bled gastrointestinal, obstruction or bad absorption 15. Dementia. 16, Patient no enabled to sign the informed consent and that does not been suffering a acute critical disease. 17, Previous treatment with radiotherapy or systemic chemotherapy. 18. To use glucocorticoid during last the 6 months. 19. To consume active illegal drug (except cannabis) during the 6 previous months to the inclusion in the study. 20. If one is a woman, pregnancy or breast-feeding. 21. Not availability to go to the programmed visits. 22. Patients who participate in another clinical trial
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients who recover the immune-specific responses against tetanus toxin and hepatitis A at week 24. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Not to adminstrate Hormone of Growth |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |