HIV seropositive MedDRA version: 14.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10058315 Term: HIV disease progression System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Cozaar 50 mg comprimidos recubiertos con película
Cozaar 100 mg comprimidos recubiertos con película
Product Name: Cozaar 50 mg comprimidos recubiertos con película
Pharmaceutical Form: Ta
Sponsors
Fundació Clínic de Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients older than 18 years. 2. Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL 250 cells/mm3. 4. Patients, properly informed, give their written consent to participate in the study. 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 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Criteria for patients with AIDS. 2. Patients with active opportunistic diseases. 3. Patients coinfected with HCV. 4. Patients without tonsillar tissue. 5. Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II. 6. Kidney failure.(Glomerular Filtration Rate (GFR 60% ). 8. Pregnant women 9. Known hypersensitivity or contraindication to any study drug. 10. determination of blood pressure (BP) <100/60 mmHg 11. Hyponatremia with serum Na numbers <132 Meq / l 12. History of chronic vomiting the last 6 months 13. History of chronic diarrhea the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.;Secondary Objective: 1. Changes in markers of fibrosis and immune recovery TL: the ratio of MMP-9/TIMP-1 and MMP-2 / TIMP-2 in the TL, Changes in the count of CD4 + T cells in peripheral blood and LT changes the CD4/CD8 ratio in peripheral blood, changes in the value of HIV viral load in peripheral blood and LT. 2. Changes in markers of atherosclerosis: To determine the levels of IL-6, D-dimer and CRP in the different groups and changes in the diameter of the carotid intima as a marker of atherosclerosis. 3. Changes in markers of dementia and CNS inflammation: measuring levels of metalloproteinases and their inhibitors in cerebrospinal fluid, as well as beta2-microglobulin levels and levels of cells and proteins. Changes in neuropsychological test diagnosis of CDS. 4. Adverse Events.;Primary end point(s): Proporción de pacientes con disminución del 50% de fibrosis en TL.;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proporción de pacientes con cambios en los niveles de IL-6, D-dímero y PCR ultrasensible en los diferentes grupos. - Proporción de pacientes con aumento de CD4 en sangre periférica y en TL en los diferentes grupos. - Proporción de pacientes con carga viral indetectable en plasma y disminuida en TL en los diferentes grupos - Proporción de pacientes con cambios en el cociente CD4/CD8 en sangre periférica en los diferentes grupos. - Proporción de pacientes con disminución del complejo íntima media en la ecografía carotídea en los diferentes grupos. - Proporción de pacientes con cambios en niveles de metaloproteasas y sus inhibidores , beta2 -microglobulina y células y proteínas en LCR. - Proporción de pacientes con mejoría de los test neuropsicologicos de CDS - Incidencia y tipos de efectos adversos clínicos y alteraciones analíticas en los diferentes grupos.;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Spain
Contacts
Public ContactCTU clinic-Farmacología clinica
Fundació Clinic per a la Recerca Biomèdica
Outcome results
None listed