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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

435

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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
Legemiddel: 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
Legemiddel: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Eksperimentell: 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
Legemiddel: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
Legemiddel: 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.
Eksperimentell: 3

LPV/r:

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

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut de Recherche pour le Developpement

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2008

Primær fullføring (Faktiske)

1. november 2010

Studiet fullført (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først innsendt

8. desember 2006

Først innsendt som oppfylte QC-kriteriene

8. desember 2006

Først lagt ut (Anslag)

11. desember 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. januar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. januar 2016

Sist bekreftet

1. januar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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Kliniske studier på HIV-infeksjoner

Kliniske studier på Maternal and infant nevirapine

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