HIV-1
Conditions
Interventions
Trade Name: Genotonorm
Product Name: somatotropina
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SOMATOTROPINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Bonaventura Clotet Sala
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients who recover the immune-specific responses against tetanus toxin and hepatitis A at week 24.;Main Objective: 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. ;Secondary Objective: 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. | — |
Countries
Spain
Outcome results
None listed