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Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial (LEOPARD)

31. juli 2020 opdateret af: Louise Kuhn, Columbia University

The investigators propose a non-randomized clinical trial of 60 HIV-infected infants identified within 48 hours of birth and their mothers to investigate the consequences of very early ART on the establishment and maintenance of the viral reservoir.

The first phase (early ART initiation within 48 hours of birth) will examine the trajectory i.e. changes over time of the viral reservoir and detection of HIV-specific antibody responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.

Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are associated with the extent of seeding and rate of decline of the viral reservoir when ART is started at a young age and investigate whether markers in infant stool samples can be used as a non-invasive method of defining relevant immune and HIV-specific parameters associated with viral reservoir size.

The investigators hypothesize that developmental characteristics of newborn immunity may make this period the optimal time to begin ART and influence the seeding of the viral reservoir.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Prevention of mother-to-child transmission (PMTCT) programs using antiretrovirals (ARVs) have had tremendous success in sub-Saharan Africa. However, HIV transmission continues to occur because (1) implementation of PMTCT is incomplete and (2) ARV interventions are not 100% effective in blocking infection. Thus the challenge of providing treatment to HIV-infected children is far from over. The capacity of early ART treatment to favorably influence the viral reservoir and potentially lead to post-treatment cessation viral control needs to be described in the population of infants, and to identify useful public health strategies.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

73

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika
        • Rahima Moosa Mother and Child 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

Ikke ældre end 2 dage (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Point of care (POC) or laboratory-based test positive on a sample collected within 48 hours of birth.
  • Mother willing and able to provide informed consent.

Exclusion Criteria:

  • Expressed intention to leave the Johannesburg area permanently.
  • Co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life.
  • Co-morbidities or conditions which in the opinion of the clinical team advise against initiation of ART within the first 48 hours of life.
  • Active (uncontrolled) maternal psychiatric illness.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Early ART
All infants enrolled in the trial, regardless of maternal PMTCT regimen, will be initiated on a triple ARV regimen consisting of nevirapine (NVP), zidovudine (ZDV) and lamivudine (3TC) presumptively based on the initial positive result. This regimen will be continued to 42 weeks post menstrual age (PMA). At this time, infants will be switched to LPV/r, ZDV and 3TC to be continued to 104 weeks or longer unless otherwise preferred by the treating clinician or if any clinical or laboratory contraindications are identified.
Medicin: Nevirapine

Standard medication used to treat and prevent HIV/AIDS, specifically HIV-1. It is generally recommended for use with other antiretroviral medication.

The initial dose of NVP will be 6 mg per kg per dose orally twice daily until 42 weeks gestational age (2 weeks of age for infants born at term) which is the dosing selected by the NIH International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network.

Andre navne:
  • Viramune
  • NVP
Medicin: Zidovudine

An antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretroviral.

ZDV will be dosed as per standard guideline and routine practices.

Andre navne:
  • ZDV
  • Retrovir
Medicin: Lamivudine

An antiretroviral medication used to prevent and treat HIV/AIDS. It is effective against both HIV-1 and HIV-2.

3TC will be dosed as per standard guideline and routine practices.

Andre navne:
  • 3TC
  • Epivir
Medicin: LPV/r

Lopinavir is an antiretroviral of the protease inhibitor class. It is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir.

LPV/r will be dosed as per standard guideline and routine practices.

Andre navne:
  • Ritonavir-boosted lopinavir

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of patients with initial viral suppression
Tidsramme: 24 weeks
Suppression is defined as patients with plasma HIV RNA <50 copies/mL.
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of patients maintaining viral suppression
Tidsramme: Between 24 and104 weeks
Suppression is defined as patients with plasma HIV RNA <50 copies/mL.
Between 24 and104 weeks
Prevalence of CD4 percentage greater than 30
Tidsramme: By 24 weeks and sustained through 104 weeks
Patients that reached a normal CD4% level.
By 24 weeks and sustained through 104 weeks
Prevalence of growth along curve within one standard deviation or upward trend
Tidsramme: Up to 104 weeks
By comparing viral growth curves.
Up to 104 weeks
Prevalence of detection of specific HIV antibody classes
Tidsramme: 24 and 104 weeks
HIV antibody detection
24 and 104 weeks
Size of the viral reservoir (copies/million cell)
Tidsramme: Up to 104 weeks
Quantification of viral reservoir
Up to 104 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Columbia University

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
University of Witwatersrand, South Africa

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

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 (Faktiske)

1. august 2015

Primær færdiggørelse (Faktiske)

30. april 2020

Studieafslutning (Faktiske)

30. april 2020

Datoer for studieregistrering

Først indsendt

28. april 2015

Først indsendt, der opfyldte QC-kriterier

30. april 2015

Først opslået (Skøn)

1. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AAAO5011
  • U01HD080441 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Contact PI Non-identifying data

IPD-delingstidsramme

Based on availability of resources

IPD-delingsadgangskriterier

Scientific justification

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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