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A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Ritonavir

+ Nelfinavir mesylate
+ Saquinavir
Medicamento
Quiénes están siendo reclutados

HIV Infections

De 3 a 16 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 29 de octubre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors. Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. \[AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.\] Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two \[AS PER AMENDMENT 11/24/99: one or two\] NRTIs of choice. Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death, cancer, or fetal abnormality. NRTIs are not provided as part of this study. \[AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.\]

Título OficialA Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 29 de octubre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 50 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 3 a 16 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Your child may be eligible for this study if he or she: * Is HIV-positive. * Is 3 to 16 years of age (consent of parent or guardian is required). * Has an HIV level greater than 10,000 copies/ml. * Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine. * Is able to swallow capsules and tablets. Exclusion Criteria Your child will not be eligible if he or she: * Has cancer requiring chemotherapy. * Has an acute opportunistic (AIDS-related) infection requiring therapy. * Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry. * Has ever taken SQV or NFV. * Is pregnant or breast-feeding. * Is taking certain medications, including those that would interfere with the study drugs.



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 36 ubicaciones
Suspendido
Univ of Alabama at Birmingham / Childrens Hosp of ALBirmingham, United StatesVer ubicación
Suspendido
Univ of Alabama at Birmingham - PediatricBirmingham, United States
Suspendido
Long Beach Memorial (Pediatric)Long Beach, United States
Suspendido
Los Angeles County - USC Med CtrLos Angeles, United States

Completado36 Centros de Estudio