Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
Indinavir sulfate
+ Ritonavir
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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 must have: HIV infection. CD4 cell count greater than 100 cells/microliter. HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay. No acute illness. Consent of parent or guardian if less than legal age. No prior enrollment in this study. All entry criteria for this study met within 15 days prior to enrollment. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Any condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study. Concurrent Medication: Excluded: Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen. Any of the following medications with ritonavir: midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine. Any of the following medications with indinavir: terfenadine, astemizole, cisapride, triazolam, midazolam. No requirement for rifampin or ketoconazole. Any concurrent treatment with other protease inhibitors. Other concurrent medication (including over-the-counter medicine or alcohol) without the knowledge and permission of the primary investigator. Patients with the following prior conditions are excluded: History of significant drug hypersensitivity. Psychiatric illness that precludes compliance with the protocol. Receipt of investigational drug within 30 days prior to administration of study drug. History of acute or chronic pancreatitis. Anticipation of poor patient compliance with protocol. Prior Medication: Excluded: Prior treatment with ritonavir. Risk Behavior: Excluded: History of active substance abuse (i.e., recreational drugs or alcohol). Included: - Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.
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 6 ubicaciones
Tower Infectious Diseases
Los Angeles, United StatesUrgent Care Ctr / North Broward Hosp District
Fort Lauderdale, United StatesGoodgame Med Ctr / Central Florida Research Initiati
Maitland, United States