ESTUDIO DE UNA DOBLE ESTRATEGIA PARA INDUCIR Y EXPANDIR EL REPERTORIO DE CÉLULAS T BASADA EN LA ADMINISTRACIÓN DE HORMONA DE CRECIMIENTO Y VACUNA EN PACIENTES CON INFECCIÓN POR EL VIH 1

• Conditions: HIV-1

• Registration Number: EUCTR2004-001413-34-ES
• Lead Sponsor: Bonaventura Clotet Sala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified