Cristin-prosjekt-ID: 2534972
Registrert av: REK Sist endret: 24. februar 2022, 14:04 Sist endret av: REK

Cristin-prosjekt-ID: 2534972
Registrert av: REK Sist endret: 24. februar 2022, 14:04 Sist endret av: REK
Prosjekt

Forebygging av mor-barn smitte med HIV med antiretrovirale medikamenter: leder dette til økt resistens mot de antiretrovirale medikamentene?

prosjektleder

Thorkild Tylleskär
ved Universitetet i Bergen

prosjekteier / koordinerende forskningsansvarlig enhet

  • Universitetet i Bergen

Godkjenninger

  • Regionale komitéer for medisinsk og helsefaglig forskningsetikk (REK) - 325477

Kategorier

Helseprosjekttype

Annet studium

Tidsramme

Aktivt
Start: 1. desember 2021 Slutt: 30. november 2026

Beskrivelse Beskrivelse

Tittel

Forebygging av mor-barn smitte med HIV med antiretrovirale medikamenter: leder dette til økt resistens mot de antiretrovirale medikamentene?

Populærvitenskapelig sammendrag

Previous studies in Zambia and other African countries have demonstrated high levels of pre-treatment HIV drug resistance in children that have been exposed to earlier versions of prophylactic drugs used in the prevention of mother-to-child transmission of HIV-1 (PMTCT). Our group has recently shown that HIV drug resistance (HIVDR) in Zambian infants upon diagnosis increased from 21% to 40%, during a study period representing three different PMTCT drug regimens, which included the universal treatment era (PMTCT option B+). Given our data that HIVDR has been on the rise despite changes in drug regimen, there is a need to determine the impact of the current, more efficacious, non-NNRTI (Non-Nucleoside Reverse Transcriptase Inhibitor) containing treatment and prevention therapies. Identification and evaluation of factors in the development of drug resistance will help determine prevention and ultimate treatment for HIV drug resistance and develop a course designed to maintain high rates of viral suppression and low rates of HIVDR. The overall aim of this work is to assess the impact of the current universal, more efficacious antiretroviral therapy for treatment and prevention of HIV, on the development of HIVDR in HIV-infected children. There are 3 specific objectives: 1. To evaluate the prevalence of pre-treatment HIVDR in HIV-infected children (0 to 2 years old), who had failed the current universal treatment PMTCT drug intervention (Option B+). 2. To compare the HIVDR patterns and magnitude in the blood and breast milk of HIV infected mothers exposed to the current PMTCT drug intervention. 3. To quantify and define the patterns of post-treatment HIVDR at 6 and 12 months of HIV treatment in HIV-infected children less than 15 years old. Study design: This will be a cross-sectional, ancillary study nested within the Phase III, multicentre, open-label, randomized controlled trial the “PROMISE-EPI” study. The main PROMISE-EPI study aims to evaluate the safety and efficacy of an innovative rescue intervention (including infant pre-exposure prophylaxis (PrEP) in high risk children) in order to protect HIV-1-exposed, uninfected infants against HIV-1 acquisition by breastfeeding. This will be done through optimizing the use of lamivudine as PrEP for high-risk children. For this purpose, the study will use recently marketed diagnostic point-of-care (POC) diagnostic tests at the first level of care for maternal HIV viral load and early infant diagnosis (EID). This POC maternal viral load will facilitate continuation of HIV prophylaxis in infants whose mothers are not HIV suppressed, while early infant diagnosis will allow optimising treatment of HIV-infected infants by offering early antiretroviral treatment initiation. The stored and prospectively collected (200-400) dry blood spot (DBS) blood samples of children less than 2 years old will be used to determine the prevalence and patterns of HIVDR in treatment naïve children. The 50 paired DBS samples of breastfeeding mother/infant and breastmilk samples from the mother will be used to compare presence and patterns of HIVDR in blood (mother and child) and breastmilk (mother). Another 300 DBS samples of children less than 15 years old who are already on treatment for 6 and 12 months with HIVDR and/or those beginning treatment with un-supressed viral load at 6 months will be used to determine the presence and pattern of post-treatment HIVDR. The DBS samples collected on follow up at 6 and 12 months will be used to determine persistence of HIVDR. Analyses: data analysis will be done using SPSS/Stata (Stata corp. TX) Study endpoints: 1. HIV-1 subtype major/minor drug resistance mutations to currently used regimens in the region. Genotypic drug resistance interpretation will be performed using the genotypic resistance algorithms provided by Stanford availablefromhttp://hivdb.stanford.edu/pages/drugSummaries_ 2. Viral load

Metode

Kvantitative analysemetoder

prosjektdeltakere

prosjektleder
Aktiv cristin-person

Thorkild Tylleskär

  • Tilknyttet:
    Prosjektleder
    ved Universitetet i Bergen

Catherine Chunda-Liyoka

  • Tilknyttet:
    Prosjektdeltaker
    ved University Teaching Hospital
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