A Phase I/II Study Of The Safety And Pharmacokinetics Of Nevirapine In HIV-1-Infected Pregnant Ugandan Women And Their Neonates (HIVNET 006)

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dc.contributor.authorMusoke, Philippa
dc.contributor.authorGuay, Laura A.
dc.contributor.authorBagenda, Danstan
dc.contributor.authorMirochnick, Mark
dc.contributor.authorNakabiito, Clemensia
dc.contributor.authorFleming, Thomas
dc.contributor.authorElliott, Terry
dc.contributor.authorHorton, Scott
dc.contributor.authorDransfield, Kevin
dc.contributor.authorPav, Joseph W.
dc.contributor.authorMurarka, Amal
dc.contributor.authorAllen, Melissa
dc.contributor.authorFowler, Mary Glenn
dc.contributor.authorMofenson, Lynne
dc.contributor.authorHom, David
dc.contributor.authorMmiro, Francis
dc.contributor.authorJackson, J. Brooks
dc.date.accessioned2022-01-29T12:46:02Z
dc.date.available2022-01-29T12:46:02Z
dc.date.issued1999
dc.description.abstractTo determine the safety, pharmacokinetics, tolerance, antiretroviral activity, and infant HIV infection status after giving a single dose of nevirapine to HIV-1-infected pregnant women during labor and their newborns during the first week of life.An open label phase I/II study.Tertiary care hospital, Kampala, Uganda.Nevirapine, 200mg, was given as a single dose during labor to 21 HIV-1-infected pregnant Ugandan women. In cohort 1, eight infants did not receive nevirapine whereas in cohort 2, 13 infants received a single dose of nevirapine, 2mg/kg, at 72h of age.The number and type of adverse events; nevirapine concentrations in the plasma and breast milk; maternal plasma HIV-1 RNA copy number before and up to 6 weeks after delivery; and HIV-1 infection status of the infants were monitored.Nevirapine was well tolerated by women and infants; no serious adverse events that were related to nevirapine were observed. Median nevirapine concentration in the women at delivery was 1623ng/ml (range 238-2356ng/ml); median cord/maternal blood ratio of 0.75 (0.37-0.93). The median half-life in women was 61.3h (27-90h) and the transplacental nevirapine half-life in infants who did not receive a neonatal dose was 54h. The median half-life after a single dose at 72h in infants was 46.5h. During the first week of life, the median colostrum/breast milk to maternal plasma nevirapine concentration was 60.5% (25-122%). The median nevirapine concentration in breast milk 1 week after delivery was 103ng/ml (25-309ng/ml). Plasma nevirapine concentrations were above 100ng/ml in all infants from both cohorts tested at age 7 days. Maternal HIV-1 RNA levels decreased by a median of 1.3 logs at 1 week postpartum, and returned to baseline by 6 weeks postpartum. Detectable plasma HIV-1 RNA was observed in one out of 22 (4.5%) infants at birth; three out of 21 (14%) at 6 weeks; and four out of 21 (19%) at 6 months of age.The administration of a single dose of nevirapine to women during labor and to their newborns at 72h was well tolerated and showed potent antiretroviral activity in the women at 1 week after dosing without rebound above baseline 6 weeks after a single dose. The nevirapine concentration was maintained above the target of 100ng/ml in infants at age 7 days, even in those infants not receiving a neonatal dose. This regimen has promise as prophylaxis against intrapartum and early breast milk transmission in a breastfeeding population.en_US
dc.identifier.citationMusoke, P., Guay, L. A., Bagenda, D., Mirochnick, M., Nakabiito, C., Fleming, T., ... & Jackson, J. B. (1999). A phase I/II study of the safety and pharmacokinetics of nevirapine in HIV-1-infected pregnant Ugandan women and their neonates (HIVNET 006). Aids, 13(4), 479-486.en_US
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/1609
dc.language.isoenen_US
dc.publisherAidsen_US
dc.subjectHIV vertical transmission, nevirapine, pharmacokinetics, Ugandaen_US
dc.titleA Phase I/II Study Of The Safety And Pharmacokinetics Of Nevirapine In HIV-1-Infected Pregnant Ugandan Women And Their Neonates (HIVNET 006)en_US
dc.typeArticleen_US
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