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Toxicidad de la clindamicina como profilaxis para la encefalitis toxoplasmática asociada al SIDA. Programas
M A Jacobson1, C L Besch, C Child
1Department of Medicine, University of California, San Francisco.
Lancet (London, England)
|February 8, 1992
Resumen
La profilaxis de clindamicina para la encefalitis toxoplasmática en pacientes con VIH condujo a eventos adversos significativamente más, incluyendo diarrea y erupción, lo que resultó en la interrupción del ensayo. La profilaxis de pirimetamina continúa en el estudio en curso.
Área de la Ciencia:
- Enfermedades infecciosas Enfermedades infecciosas.
- Farmacología clínica Farmacología clínica.
- El VIH Medicina El VIH Medicina
Sus antecedentes:
- La encefalitis toxoplasmática (TE) es una infección oportunista grave en pacientes infectados por el VIH.
- La profilaxis es crucial para prevenir la TE en individuos en riesgo.
- Las opciones profilácticas existentes requieren una evaluación cuidadosa de la seguridad y la eficacia.
Objetivo del estudio:
- Para comparar la seguridad y eficacia de la clindamicina frente a la pirimetamina para la profilaxis de TE en pacientes infectados por el VIH.
- Para evaluar la incidencia de eventos adversos asociados con la profilaxis de la clindamicina.
- Determinar la necesidad de una terminación temprana del ensayo basado en datos provisionales de seguridad.
Principales métodos:
- Se realizó un ensayo doble ciego controlado con placebo.
- Los participantes eran pacientes infectados por el VIH en riesgo de encefalitis toxoplasmática.
- Los pacientes recibieron clindamicina, pirimetamina o placebo.
Principales resultados:
- El tratamiento con clindamicina se asoció con un aumento de 4.4 veces la probabilidad de eventos adversos que requieren la retirada del medicamento en comparación con el placebo.
- La diarrea (31%) y el sarpullido (21%) fueron significativamente más frecuentes en el grupo de clindamicina.
- El brazo de clindamicina del ensayo fue terminado prematuramente debido a preocupaciones de seguridad.
Conclusiones:
- La profilaxis de la clindamicina para la TE en pacientes con VIH se asocia con una alta tasa de eventos adversos.
- Los eventos adversos observados requirieron la terminación temprana del brazo de tratamiento con clindamicina.
- Se están llevando a cabo más investigaciones sobre la profilaxis de la pirimetamina para la TE en esta población.
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