- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00929604
HIV Viral Load Monitoring in Resource-Poor Settings
Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings
No randomized clinical trial to date has demonstrated a survival benefit of using regular HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to monitor the response to ART in developed countries. In resource-constrained settings, the World Health Organization (WHO) does not recommend routine VL testing, in part due to the cost and complex infrastructure needed for reliable results. In these settings, WHO has proposed the use of clinical and CD4+ lymphocyte-based criteria to guide treatment decisions. However, multiple studies have demonstrated the poor performance of these criteria in sub-Saharan Africa and the frequent discordance between immunologic and virologic responses to ART.
The use of routine viral load monitoring should be evaluated in resource-constrained settings. The investigators hypothesize that routine viral load testing of patients on ART will improve patient survival, decrease disease progression and development of drug resistance, and will be feasible and cost-effective for resource-constrained settings.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Lusaka, Zambia
- Centre for Infectious Disease Research in Zambia
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Documented HIV-1 infection (according to local standard rapid testing algorithms)
- Age 18 years or greater
- Able and willing to provide informed consent to participate
Eligible for antiretroviral therapy per Zambian national guidelines, which are any of the following:
- CD4+ cell count less than 200 cells/mm3;
- WHO Stage IV disease; or
- WHO Stage III disease and CD4+ cell count less than 350 cells/mm3
- Residence in the geographical catchment area of the VLS clinic and intent to remain there for the duration of the study
- Willingness to adhere to the study visit schedule and to be followed-up at home in the event of a missed study visit
- Initiating ART on the day of VLS enrollment, informed consent, and baseline blood collection
Exclusion Criteria:
- Receipt of more than 7 days (cumulative) of prior antiretroviral therapy at any time prior to study entry, with the exception of zidovudine and/or single dose nevirapine for prevention of mother-to-child transmission;
- Any exposure to antiretroviral therapy in the past one month
- A condition that, in the opinion of the investigators, would interfere with adherence to study requirements (e.g., mental illness or active drug or alcohol use or dependence)
- Serious illness requiring referral to hospital at the time of ART initiation
- For patients seeking care at sites randomized to the standard of care arm: participation in another research protocol that offers routine viral load testing
- Unwillingness to consent to all aspects of study protocol including blood specimen storage
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Standard of care
Standard of care arm: utilizes the current standard of care per Zambian national guidelines to determine treatment failure and eligibility for second-line ART.
HIV-1 viral load measurement is performed if the criteria for either immunologic (i.e., CD4+ lymphocyte count-based) or clinical treatment failure are fulfilled.
If both immunologic and clinical treatment failure criteria are fulfilled, the ART regimen is changed to second-line without VL testing.
|
|
Experimental: Routine HIV-1 viral load testing
Routine viral load testing arm: Routine HIV viral load testing at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30 and 36 months thereafter.
|
Plasma HIV-1 RNA viral load testing performed at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30, and 36 months thereafter.
Routine viral load results are provided to clinicians for the management of the participant's HIV treatment.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Supervivencia del paciente
Periodo de tiempo: 36 meses
|
36 meses
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To assess HIV clinical disease progression (weight, CD4 cell response, incident opportunistic infections)
Periodo de tiempo: 36 months
|
36 months
|
To assess the impact of more rapid ART regimen switching on available second and third-line treatment options
Periodo de tiempo: 36 months
|
36 months
|
To monitor the effectiveness of newer antiretroviral medications introduced in Zambia (principally tenofovir)
Periodo de tiempo: 36 months
|
36 months
|
To characterize the timing and sequence of HIV drug resistance development among patients in each study arm
Periodo de tiempo: 36 months
|
36 months
|
To assess the feasibility, acceptability, and cost effectiveness of the two management strategies in a resource-constrained sub-Saharan African setting
Periodo de tiempo: 36 months
|
36 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael S. Saag, M.D., University of Alabama at Birmingham
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- VLS
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Infecciones por VIH
-
Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
-
Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
-
China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán
Ensayos clínicos sobre HIV-1 viral load testing
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)Terminado
-
Johns Hopkins UniversityAún no reclutando
-
Merck Sharp & Dohme LLCTerminado
-
Wellness Wheel Medical ClinicUniversity of Saskatchewan; Saskatchewan Health Authority - Regina Area; CIHR Canadian...ReclutamientoInfecciones por VIH | SífilisCanadá
-
Merck Sharp & Dohme LLCTerminado
-
MRC/UVRI and LSHTM Uganda Research UnitKarolinska Institutet; Amsterdam Institute for Global Health and Development; University... y otros colaboradoresReclutamientoVIH | La carga viral | Monitoreo en el punto de atenciónKenia, Uganda
-
Johns Hopkins UniversityCenters for Disease Control and PreventionReclutamientoInfecciones por VIH | SífilisEstados Unidos
-
National Institute of Allergy and Infectious Diseases...AIDS Clinical Trials Group; Acute Infection and Early Disease Research ProgramTerminadoInfecciones por VIHEstados Unidos, Samoa Americana, Australia
-
National Institute of Allergy and Infectious Diseases...Genentech, Inc.; BiocineTerminadoInfecciones por VIH | Seronegatividad del VIHEstados Unidos, Puerto Rico