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Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand (PHPT-5)

26 de enero de 2016 actualizado por: Marc Lallemant, Institut de Recherche pour le Developpement

Maternal and Infant Peripartum Nevirapine, Versus Infant Only Peripartum Nevirapine, or Maternal Lopinavir/Ritonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand.

The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention of mother-to-child transmission of HIV-1.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Multicenter, placebo-controlled, double blind, clinical trial where non immunocompromised women receiving the ZDV prophylaxis regimen from 28 weeks gestation, as recommended in Thailand, will be randomized to one of two arms:

Arm 1: NVP-NVP:

  • In women, one NVP 200 mg tablet at onset of labor+;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours+++

Arm 2: PL-NVP:

  • In women, one placebo tablet at onset of labor++;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours+++

Arm 3: LPV/r:

  • In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

    • women in Arm 1 will also receive 7-day ZDV 300mg bid plus 3TC 150mg bid from delivery. ++women in Arm 2 will also receive 7-day (ZDV+3TC) Placebo from delivery. +++If the new born weight less than 2500 g, nevirapine will be administered 2 mg./1 kg (As per Thai Guideline).

All infants will receive ZDV for at least one week. Follow-up of women and infants is carried out on an outpatient basis except for delivery and the first three days after delivery. Mothers and infants are followed-up for 24 months after delivery.

Note: The study was stopped and data unblinded upon DSMB recommendations in September 2010 because of changes in Thai PMTCT guidelines recommending use of HAART in all HIV infected pregnant women regardless of their CD4 count. At the time of unblinding 435 pregnant women had been enrolled and follow-up of these women and their children is continuing.

Tipo de estudio

Intervencionista

Inscripción (Actual)

435

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

  • Tailandia
      • Bangkok, Tailandia, 10220
        • Health Promotion Hospital Regional Center I
      • Chiang Mai, Tailandia, 50100
        • Health Promotion Center Region 10,
      • Chiang Mai, Tailandia, 50110
        • Fang Hospital
      • Chiang Mai, Tailandia, 50160
        • Chomthong hospital
      • Chonburi, Tailandia, 20180
        • Somdej Pranangchao Sirikit Hospital
      • Khon Kaen, Tailandia, 40000
        • Regional Health Promotion Centre 6,
      • Lamphun, Tailandia, 51000
        • Lamphun Hospital
      • Phayao, Tailandia, 56000
        • Phayao Provincial Hospital
      • Phuket, Tailandia, 83000
        • Vachira Phuket Hospital
      • Samutprakarn, Tailandia, 10280
        • Samutprakarn Hospital
    • Bangkok
      • Kannayao, Bangkok, Tailandia, 10230
        • Nopparat Rajathanee Hospital
      • Saimai, Bangkok, Tailandia
        • Bhumibol Adulyadej Hospital
    • Chachoengsao
      • Muang, Chachoengsao, Tailandia, 24000
        • Chachoengsao Hospital
    • Chantaburi
      • Muang, Chantaburi, Tailandia, 22000
        • Prapokklao Hospital
    • Chiang Mai
      • Mae Rim, Chiang Mai, Tailandia, 50180
        • Nakornping Hospital
      • Sanpatong, Chiang Mai, Tailandia
        • Sanpatong Hospital
    • Chiang Rai
      • Mae Chan, Chiang Rai, Tailandia
        • Mae Chan Hospital
      • Mae Sai, Chiang Rai, Tailandia
        • Mae Sai Hospital
      • Phan, Chiang Rai, Tailandia
        • Phan Hospital
    • Chiangrai
      • Chiang Saen, Chiangrai, Tailandia, 57150
        • Chiang Saen Hospital
      • Muang, Chiangrai, Tailandia, 57000
        • Chiangrai Prachanukroh Hospital
      • Wiangpapao, Chiangrai, Tailandia, 57170
        • Wiangpapao Hospital
    • Chonburi
      • Banglamung, Chonburi, Tailandia, 20150
        • Banglamung Hospital
      • Muang, Chonburi, Tailandia, 20000
        • Chonburi Hospital
      • Panasnikom, Chonburi, Tailandia, 20140
        • Panasnikom Hospital
      • Sri Racha, Chonburi, Tailandia, 20230
        • Ao Udom Hospital
    • Kalasin
      • Muang, Kalasin, Tailandia, 46000
        • Kalasin Hospital
    • Kanjanaburi
      • Munag, Kanjanaburi, Tailandia, 71000
        • Phaholpolphayuhasena Hospital
    • Khon Kaen
      • Muang, Khon Kaen, Tailandia
        • Khon Kaen Hospital
    • Lampang
      • Muang, Lampang, Lampang, Tailandia, 52000
        • Lampang Hospital
    • Mahasarakam
      • Muang, Mahasarakam, Tailandia, 44000
        • Mahasarakam Hospital
    • Nakhon Si Thammarat
      • Muang, Nakhon Si Thammarat, Tailandia, 80000
        • Maharaj Nakhon Si Thammarat Hospital
    • Nakhonpathom
      • Muang, Nakhonpathom, Tailandia
        • Nakhonpathom Hospital
    • Nong Kai
      • Muang, Nong Kai, Tailandia, 43000
        • Nong Khai Hospital
    • Nonthaburi
      • Muang, Nonthaburi, Tailandia
        • Pranangklao Hospital
    • Pathumthani
      • Muang, Pathumthani, Tailandia, 12000
        • Pathumthani Hospital
    • Phayao
      • Chiang Kham, Phayao, Tailandia, 56110
        • Chiang Kham Hospital
    • Pitsanulok
      • Muang, Pitsanulok, Tailandia
        • Buddhachinaraj Hospital
    • Rayong
      • Muang, Rayong, Tailandia, 21000
        • Rayong Hospital
    • Samutsakhon
      • Muang, Samutsakhon, Tailandia, 74000
        • Samutsakhon Hospital
    • Songkhla
      • Muangsongkhla, Songkhla, Tailandia, 90100
        • Songkhla Hospital
    • Songkla
      • Hat Yai, Songkla, Tailandia, 90110
        • Hat Yai Hospital
    • Trat
      • Muang, Trat, Tailandia, 23000
        • Trat 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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Pre-Entry Criteria

  • Evidence of HIV infection (documented by two HIV antibody tests on two different dates)
  • Intend to be followed at a study site for the duration of the study
  • At least 18 years old
  • Written informed consent.

Inclusion Criteria:

Women are eligible for the study if they

  • met all pre-entry criteria
  • Evidence of HIV infection, as documented by two serology tests obtained at two different dates;
  • between 28 and 36 weeks gestational age;
  • antiretroviral naïve except for exposure to ZDV prophylaxis PMTCT;
  • CD4 count above 250 cells/mm3 (within 4 months prior to randomization)
  • agreement not to breastfeed;
  • consent to participate and to be followed for the duration of the study;
  • and the following laboratory values within 14 days prior to randomization:
  • hemoglobin > 8.5 mg/dl;
  • absolute neutrophil count > 750 cells/mm3;
  • platelets > 50,000 cells/mm3;
  • SGPT ≤ 5 times upper limit of normal;
  • serum creatinine ≤ 1.5 times upper limit of normal (women with a serum creatinine > 1.5 times upper limit of normal must have a measured eight-hour urine creatinine clearance > 70 ml/min).

Exclusion criteria:

  • Evidence of pre-existing fetal anomalies incompatible with life;
  • patients who meet the criteria of Classes III/IV of the WHO classification of HIV-associated clinical disease;
  • known hypersensitivity to any benzodiazepine;
  • active tuberculosis;
  • concurrent participation to any other clinical trial;
  • receipt of benzodiazepines or antiretroviral agent other than ZDV;
  • uncontrolled hypertension;
  • anticoagulant therapy or magnesium sulfate within 2 weeks of enrollment or the need for them during labor or at delivery.

If any of these conditions occurs after randomization, the women will be excluded from study drug dosing. Women with CD4 count lower than 250 cells/mm3 will be excluded from the study and offered HAART in the context of the national program.

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 1

NVP-NVP:

  • In women, one NVP 200 mg tablet at onset of labor;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Droga: Maternal and infant nevirapine
  • In women, one NVP 200 mg tablet at onset of labor;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately
Droga: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Experimental: 2

PL-NVP:

  • In women, one placebo tablet at onset of labor;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Droga: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Droga: Maternal placebo and infant nevirapine
  • In women, one placebo tablet at onset of labor;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours

Comparison between Arms 1 and 2 is double-blinded.
Experimental: 3

LPV/r:

  • In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
Droga: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Droga: Maternal lopinavir+ritonavir
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
Periodo de tiempo: At birth, 7-10 days, 1, 2, 4 and 6 months of age
At birth, 7-10 days, 1, 2, 4 and 6 months of age

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Safety for mothers and children of two NVP doses in neonates with and without maternal single dose NVP at onset of labor or LPV/r from 28 weeks gestation.
Periodo de tiempo: From randomization during pregnancy until 24 months after delivery
From randomization during pregnancy until 24 months after delivery

Colaboradores e Investigadores

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

Patrocinador

Institut de Recherche pour le Developpement

Colaboradores

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Harvard School of Public Health (HSPH)

Investigadores

  • Investigador principal: Marc Lallemant, MD, Institut de Recherche pour le Developpment

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

Enlaces Útiles

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 julio de 2008

Finalización primaria (Actual)

1 de noviembre de 2010

Finalización del estudio (Actual)

1 de junio de 2015

Fechas de registro del estudio

Enviado por primera vez

8 de diciembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

8 de diciembre de 2006

Publicado por primera vez (Estimar)

11 de diciembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de enero de 2016

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

26 de enero de 2016

Última verificación

1 de enero de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PHPT-5 First Phase
  • R01HD052461 (Subvención/contrato del NIH de EE. UU.)
  • R01HD056953 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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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