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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. januar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

435

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Medicin: 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
Medicin: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Eksperimentel: 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
Medicin: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Medicin: 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.
Eksperimentel: 3

LPV/r:

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: From randomization during pregnancy until 24 months after delivery
From randomization during pregnancy until 24 months after delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut de Recherche pour le Developpement

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Marc Lallemant, MD, Institut de Recherche pour le Developpment

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

8. december 2006

Først indsendt, der opfyldte QC-kriterier

8. december 2006

Først opslået (Skøn)

11. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PHPT-5 First Phase
  • R01HD052461 (U.S. NIH-bevilling/kontrakt)
  • R01HD056953 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Maternal and infant nevirapine

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