Olagunju, A 
ORCID: 0000-0002-6588-5749, Anweh, D, Okafor, O, Dickinson, L ORCID: 0000-0001-5557-9396, Richman, D, Owen, A ORCID: 0000-0002-9819-7651 and Adejuyigbe, E
(2019)
Viral and antiretroviral dynamics in HIV mother-to-child transmission fluids (VADICT) – Protocol and data analysis plan for a cohort study [version 1; peer review: 1 approved with reservations]
Wellcome Open Research, 4.
p. 34.
ISSN 2398-502X, 2398-502X
Abstract
Background: Pregnancy and polymorphisms in drug disposition genes alter the clearance of key antiretrovirals used as part of regimens for prevention of mother-to-child transmission of HIV (PMTCT). The clinical significance of these in women initiating therapy late in pregnancy has not been investigated. The primary objective of the Viral and Antiretroviral Dynamics in HIV Mother-To-Child Transmission Fluids (VADICT) study is to investigate viral and antiretroviral dynamics in matrices associated with mother-to-child transmission (MTCT) (plasma, genital fluid and breastmilk) in women (stratified by CYP2B6 genotypes) who initiate antiretroviral therapy (ART) before or early in pregnancy versus late in pregnancy or early postpartum. Methods: A cohort of HIV-1 infected women who initiated ART containing 600 mg efavirenz before or early in pregnancy (n = 120), during the third trimester (n = 60), or early postpartum (n = 60) will be studied. Eligible patients will be recruited from four hospitals in Benue State, North Central Nigeria and followed until the end of breastfeeding. Procedures at follow up visits will include sample collection for drug quantification and HIV-1 RNA and DNA in plasma, genital fluid and breastmilk; adherence monitoring; and newborn and infant assessment. Using newborn exposure to maternal efavirenz at birth for validation, prenatal pharmacogenetics of efavirenz will be explored using physiologically-based pharmacokinetic modelling. Three integrated methods will be used to monitor patterns and correlates of adherence across pregnancy and the breastfeeding period. A population pharmacokinetic-pharmacodynamic model will be developed to describe the observed data and simulate what to expect in women initiating ART containing 400 mg efavirenz (recently approved for non-pregnant adults) late in pregnancy or early postpartum. Discussion: This study will help in understanding residual MTCT in women receiving ART and reasons for the rise in MTCT risk during the breastfeeding period. Trial registration: ClinicalTrials.gov: NCT03284645 (15/09/2017).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | 3207 Medical Microbiology, 3215 Reproductive Medicine, 32 Biomedical and Clinical Sciences, Breastfeeding, Lactation and Breast Milk, Pregnancy, Pediatric Research Initiative, Maternal Health, Patient Safety, Women's Health, Infectious Diseases, HIV/AIDS, Genetics, Maternal Morbidity and Mortality, Prevention, Perinatal Period - Conditions Originating in Perinatal Period, Pediatric AIDS, Clinical Research, Reproductive health and childbirth, Infection, 3 Good Health and Well Being |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 21 Feb 2020 16:42 |
| Last Modified: | 24 Jan 2026 01:56 |
| DOI: | 10.12688/wellcomeopenres.15072.1 |
| Open Access URL: | https://wellcomeopenresearch.org/articles/4-34/v1 |
| Related Websites: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3076082 |
| Disclaimer: | The University of Liverpool is not responsible for content contained on other websites from links within repository metadata. Please contact us if you notice anything that appears incorrect or inappropriate. |
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