Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study
Descripción general del estudio
Descripción detallada
The drug regimen for treatment of HIV at the free ART centers in India includes stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on this regimen experience drug toxicity within the first six months of treatment.
The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART in the Indian governmental program, because it is more expensive than the other drug regimens, in spite of better clinical outcomes in resource limited settings. The cost of treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred first line treatment, but we believe that although the direct cost to the government is less, patients on zidovudine/stavudine regimen have to spend more money for additional hospital visits and admissions, laboratory investigations and other medications due to ART induced toxicity.
There are no published data including economic, clinical and quality of life outcomes to compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative effectiveness study will seek to identify the best treatment for HIV patients based on the incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.
The clinical outcomes include viral suppression, change in the CD4 and proportion of patients with toxicity and opportunistic infections. Direct costs for the treatment will be calculated. The QOL scores will be estimated and compared between the regimens using questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tamilnadu
-
Vellore, Tamilnadu, India, 632004
- Christian Medical College
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All treatment naïve patients above 18 years confirmed with the diagnosis of HIV
- Eligible for initiation of cART based on the National Aids Control Organization of India
- Consenting for participation and follow-up for one year.
Exclusion Criteria:
- All patients requiring hospitalization at the time of initiation of treatment
- Patients with opportunistic infections including tuberculosis
- Patients with co-morbidities like diabetes or neurological impairments
- Pregnant and breast feeding women and children less than 18 years will be excluded
- All patients living outside the catchment area of CMC and not willing for regular follow-up will be excluded
- Patients with a creatinine clearance less than 50 mL/min will be excluded.
- Patients receiving other co-medications with possible interaction with tenofovir, like antifungal (voriconazole), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, and methylergonovine), benzodiazepines (midazolam, triazolam), calcium channel blocker (bepridil), GI motility agent (cisapride), neuroleptic (pimozide) and St.John's wort will be excluded.
- Patients with hemoglobin less than 8 gm/dl
- Patients started on tenofovir regimen by the treating physician at the time of enrollment will be excluded
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
|
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Otros nombres:
|
|
Comparador activo: Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
|
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Viral suppression
Periodo de tiempo: End of follow-up : end of 12th Month
|
End of follow-up : end of 12th Month
|
|
Change in CD4 levels
Periodo de tiempo: End of Months 6 and 12
|
End of Months 6 and 12
|
|
Drug related toxicity
Periodo de tiempo: Months : 1,2,3,4,5,6,7,8,9,10,11,12
|
Months : 1,2,3,4,5,6,7,8,9,10,11,12
|
|
opportunistic infections
Periodo de tiempo: Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
|
Direct costs
Periodo de tiempo: Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
|
Quality of life
Periodo de tiempo: Month 1 and end of months 4,8 and 12
|
Month 1 and end of months 4,8 and 12
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Christine C Wanke, MD, Tufts University
- Investigador principal: Sowmyanarayanan V Thuppal, MD, Tufts University
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
Otros números de identificación del estudio
- 10465 (Otro identificador: Fred Hutch/University of Washington Cancer Consortium)
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 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