A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
Lopinavir/Ritonavir
+ Nevirapine
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Patients receive 1 of the following: ABT-378/RTV plus NVP plus 2 NRTIs; or Investigator-selected PI(s) plus NVP plus 2 NRTIs.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 300 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 12 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 Patients may be eligible for this study if they: Are at least 12 years old. Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml. Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks. Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir. Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have an active illness. Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry. Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI). Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry. Have received treatment with a PI other than their current PI. Are receiving chemotherapy for cancer. 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 88 ubicaciones
Univ of Alabama at Birmingham
Birmingham, United StatesAbrir Univ of Alabama at Birmingham en Google MapsPhoenix Body Positive
Phoenix, United StatesPacific Oaks Med Group
Beverly Hills, United StatesOrange County Ctr for Special Immunology
Fountain Valley, United States