A Multicenter, Open-Label, 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 200 Mg b.i.d. and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy
Indinavir sulfate
+ Ritonavir
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry. Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry. Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly). Experienced treatment failure within 24 weeks of study entry. Are 18 years of age or older. Agree to use effective barrier methods of birth control (such as condoms) during the study. Exclusion Criteria You will not be eligible for this study if you: Are allergic to ritonavir or indinavir. Have hepatitis. Have an abnormal chest x-ray or abnormal liver function tests. Have taken 2 protease inhibitors at the same time for 7 or more days. Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry. Have a medical condition that might make it unsafe for you to take the study drugs. Have experienced resistance to NRTIs and no new NRTI therapy is possible. Have taken certain medications. Abuse alcohol or drugs. Are pregnant or breast-feeding.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 8 ubicaciones
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, United StatesAbrir LAC / USC Med Ctr / Infectious Diseases en Google MapsUniv of Miami School of Medicine
Miami, United StatesNorthwestern Univ / Div of Infect Diseases
Chicago, United StatesChase Braxton Health Service
Baltimore, United States