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Breastfeeding, Antiretroviral, and Nutrition Study

22 de abril de 2010 actualizado por: Centers for Disease Control and Prevention

HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

This is a comparative clinical trial among HIV-infected women and their infants to determine:

  1. the benefit of nutritional supplementation given to women during breastfeeding
  2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
  3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include assessment of mortality and morbidity among HIV-infected women; evaluation of interventions to reduce HIV transmission to infants exposed by breast milk; and assessment of early weaning as a risk-reduction strategy for infants of HIV-infected mothers.

The study will evaluate the following:

  1. The efficacy of a high-density caloric/micronutrient nutritional supplement given to HIV-infected women who breastfeed in preventing maternal depletion (weight loss and micronutrient status).
  2. The safety and efficacy of maternal or infant antiretroviral regimens, taken for up to 6 months during breastfeeding, in reducing infant HIV infection rates at 48 weeks.
  3. The feasibility of exclusive breastfeeding for 6 months followed by rapid weaning.

Additional study objectives are to evaluate the feasibility of delivering these interventions in resource poor settings and to identify maternal, infant, and virologic factors associated with HIV transmission during breastfeeding.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2369

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Malaui
      • Lilongwe, Malaui
        • Kamuzu Central Hospital, Bottom Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Recruitment and primary eligibility criteria:

  • Age > 14 years.
  • Ability to give informed assent or consent.
  • Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
  • Currently pregnant (with a single or multiple fetuses).
  • Gestation < 30 weeks at referral from 'Call to Action' Program
  • No serious current complications of pregnancy.
  • Intention to breastfeed.
  • Intention to deliver at the institution at which the study is based.
  • Not previously enrolled in this study for an earlier pregnancy.
  • Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses.
  • No previous use of antiretrovirals including the HIVNET 012 regimen.
  • Mother's CD4 count > 250 cells/uL determined in the antenatal clinic.
  • Mother's ALT < 2.5 x ULN (upper limit of normal) determined in the antenatal clinic

Secondary eligibility criteria and treatment assignment:

  • Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
  • Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
  • Infant birth weight > 2000 g.
  • No severe congenital malformations or other condition(s) not compatible with life.
  • Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Maternal ARVs & Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother
Droga: Maternal zidovudine/lamivudine/lopinavir-ritonavir
Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
Otros nombres:
  • Combivir tabs (zidovudine 300mg and lamivudine 150mg)
  • Aluvia tabs (lopinavir 200mg /ritonavir 50mg)
Suplemento dietético: Maternal protein and calorie supplement
High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
Otros nombres:
  • Produced by Nutriset. Daily dose: 2 sachets.
Comparador activo: Infant NVP & Nutrition Supplement
Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother
Suplemento dietético: Maternal protein and calorie supplement
High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
Otros nombres:
  • Produced by Nutriset. Daily dose: 2 sachets.
Droga: Infant nevirapine

Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.

To 28 weeks while breastfeeding.

Otros nombres:
  • Viramune (Nevirapine) suspension 50mg/5ml
Comparador activo: Maternal ARVs & No Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & no nutritional supplement given to the mother
Droga: Maternal zidovudine/lamivudine/lopinavir-ritonavir
Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
Otros nombres:
  • Combivir tabs (zidovudine 300mg and lamivudine 150mg)
  • Aluvia tabs (lopinavir 200mg /ritonavir 50mg)
Comparador activo: Infant NVP & No Nutrition Supplement
Extended infant nevirapine for prophylaxis & no nutritional supplment given to the mother
Droga: Infant nevirapine

Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.

To 28 weeks while breastfeeding.

Otros nombres:
  • Viramune (Nevirapine) suspension 50mg/5ml
Comparador activo: No Drugs & Nutrition Supplement

No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis & daily nutritional supplement given to the mother.

Note: As of March 2008, the third arm of the antiretroviral intervention, in which neither mother nor infant received drugs beyond enhanced standard of care, was stopped based on recommendations of a Data and Safety Monitoring Board review of interim efficacy results and safety data after 77% participants had received treatment assignment.
Suplemento dietético: Maternal protein and calorie supplement
High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
Otros nombres:
  • Produced by Nutriset. Daily dose: 2 sachets.
Sin intervención: No Drugs & No Nutrition Supplement

No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis & no nutritional supplement given to the mother.

Note: As of March 2008, the third arm of the antiretroviral intervention, in which neither mother nor infant received drugs beyond enhanced standard of care, was stopped based on recommendations of a Data and Safety Monitoring Board review of interim efficacy results and safety data after 77% participants had received treatment assignment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Postpartum weight loss between delivery and 28 weeks
Periodo de tiempo: between delivery and 28 weeks
between delivery and 28 weeks
Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.)
Periodo de tiempo: birth to 28 weeks
birth to 28 weeks
Exclusive breastfeeding and breastfeeding cessation by 28 weeks
Periodo de tiempo: birth to 28 weeks
birth to 28 weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Duration of exclusive breastfeeding
Periodo de tiempo: birth to 28 weeks
birth to 28 weeks
Infant HIV status through 48 weeks
Periodo de tiempo: birth to 48 weeks
birth to 48 weeks
Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks
Periodo de tiempo: delivery to 48 weeks
delivery to 48 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Centers for Disease Control and Prevention

Colaboradores

University of North Carolina, Chapel Hill
Kamuzu Central Hospital

Investigadores

  • Investigador principal: Peter Kazembe, MB ChB, Kamuzu Central Hospital
  • Silla de estudio: Charles van der Horst, MD, University of North Carolina, Chapel Hill
  • Investigador principal: Denise J Jamieson, MD, MPH, CDC, Atlanta, GA

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2004

Finalización primaria (Actual)

1 de enero de 2010

Finalización del estudio (Actual)

1 de enero de 2010

Fechas de registro del estudio

Enviado por primera vez

13 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2005

Publicado por primera vez (Estimar)

14 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de abril de 2010

Última actualización enviada que cumplió con los criterios de control de calidad

22 de abril de 2010

Última verificación

1 de abril de 2010

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDC-NCCDPHP-3946
  • U48CCU409660 (Otro número de subvención/financiamiento: U.S. Centers for Disease Control and Prevention)
  • PA 04003 SIP 26-04 (Otro número de subvención/financiamiento: U.S. Centers for Disease Control and Prevention)

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. .

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