ESTUDIO DE LOS CAMBIOS EN EL RECUENTO DE LINFOCITOS CD4 TRAS LA SUSTITUCIÓN DE TENOFOVIR POR ABACAVIR EN PACIENTES CON UNA PAUTA HAART QUE INCLUYA DDI + TENOFOVIR Y CON SUPRESIÓN VIRAL

Categoría Estudio primario
Registro de estudiosEU Clinical Trials Register
Año 2005

Este artículo no está incluido en ninguna revisión sistemática

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INTERVENTION:

Trade Name: Videx Product Name: Didanosina Pharmaceutical Form: Capsule* Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200/day‐400/day Trade Name: Viread Product Name: Tenofovir disoproxil Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300/day‐ Trade Name: Ziagen Product Name: Abacavir sulfate Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600/day‐ Product Name: Abacavir sulfate + Lamivudina Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600 + 300 /day‐

CONDITION:

HIV infected patients

PRIMARY OUTCOME:

Main Objective: To evaluate the immunological response during the 48 weeks of the study Primary end point(s): CD4 cell count Secondary Objective: To evaluate the virological response; To evaluate the tolerability and safety

INCLUSION CRITERIA:

1.Age ³ 18 years old 2. HIV‐1 infected patients 3. Patients on triple HAART therapy with ddI + tenofovir + IP or NNRTI for at least the last 3 months 4. Patients with HIV viral load < 50 copy / ml for at least 6 months 5. Not being on treatment with immunosuppressors such as: hidroxiurea, interferon, ribavirina or cytostatic. 6. Not being on treatment with interleukine‐2 or other immunomodulator 7. If female, not to be childbed potential or should use a anticonceptive method during 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: fd68350103822536a581de686d40f4f30e85d347
First added on: Aug 21, 2024