None listed
Conditions
Interventions
Intervention Type of group
The investigational product will be applied intravenously in the first week and then twice a week for 6 months.
Sponsors
ARZNEIMITTEL GMBH & CO. KG BIOMUN,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient 18 years of age or older 2. Patient 65 years of age or younger in cases of chronic HVC and HIV-AIDS infection 3. Defined diagnosis of chronic HVC 4. Defined diagnosis of HIV manifested by clear signs of immunological weakness 5. Histological diagnosis defined malignant neoplasm 6. Unsuccessful treatment with Interferons (monotherapy and / or combination therapy with Ribavirin) 7. Contraindication of interferon therapies 8. Failure of therapies using protease / transcriptase inhibitors 9. Rejection of conventional therapies due to side effects or other reasons 10. Declaration of written consent by the patient to participate in the study
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Nursing Mothers 3. Acute myocardial infarction within the last 6 months 4. Alterations in heart rhythm (from Lown IVb) 5. Unstable angina pectoris 6. Surgical interventions within the last 3 months 7. Tumor involvement in patients diagnosed with HIV or HCV infection 8. Hemorrhagic diathesis, coagulopathy 9. Current drug consumption or abuse of psychoactive substances 10. Previous participation in a clinical evaluation 11. Patient under 18 years of age 12. Patient over 65 years of age in cases of chronic HVC and HIV infection 13. Limited collaboration on the part of the patient 14. Dying patients 15. Patient with severe psychiatric illness / endogenous psychosis 16. Patient with severe personality disorder psychiatrically proven 17. Patient unable to contract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical safety: non-appearance of side effects and that are not attributable to antiretroviral treatment or prophylaxis for opportunistic infections Laboratory safety: non-variation of your laboratory tests controls with respect to your baseline examinations: hemogram, liver biochemistry (Transaminases: TGO-TGP, Prothrombin time, TP, total and fractionated bilirubins: BT, BI, BD), renal biochemistry (urea, creatinine, serum electrolytes: Sodium, Potassium). Measure:Safety Timepoints:6 months 05 years ins case of cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Increase in CD4 levels progressively after 6 months of evaluation and follow-up; Progressive decrease in viral load after 6 months of evaluation and follow-up and favorable clinical evolution Measure:Efficacy of BIOMUN forte® for patients with HIV Timepoints:6 months ; Outcome name:decreased viral load levels by quantitative PCR for chronic HCV after 6 months of evaluation and follow-up Measure:Efficacy of of BIOMUN forte® for patients with chronic HCV Timepoints:6 months ; Outcome name:increase in survival time after 6 months of initial evaluation and follow-up and by medium- and long-term follow-up, as appropriate, according to the type of cancer. Improvement in the quality of life according to the Kamofsky scale. Evaluation of the return to normal life without sequelae of the disease and treatment. I return to normal values of specific ancillary tests (tumor markers). Measure:Efficacy of BIOMUN forte® for cancer patients Timepoints:5 years | — |
Countries
Peru
Outcome results
None listed