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dc.contributor.authorScarsi, Kimberly K
dc.contributor.authorCramer, Yoninah S
dc.contributor.authorRosenkranz, Susan L
dc.contributor.authorAweeka, Francesca
dc.contributor.authorBerzins, Baiba
dc.contributor.authorCoombs, Robert W
dc.contributor.authorCoughlin, Kristine
dc.contributor.authorMoran, Laura E
dc.contributor.authorZorrilla, Carmen D
dc.contributor.authorAkelo, Victor
dc.contributor.authorAziz, Mariam
dc.contributor.authorFriedman, Ruth K
dc.contributor.authorGingrich, David
dc.contributor.authorSwaminathan, Shobha
dc.contributor.authorGodfrey, Catherine
dc.contributor.authorCohn, Susan E
dc.date.accessioned2019-11-08T20:04:15Z
dc.date.available2019-11-08T20:04:15Z
dc.date.issued2019-09-01
dc.identifier.citationScarsi, K. K., Cramer, Y. S., Rosenkranz, S. L., Aweeka, F., Berzins, B., Coombs, R. W., ... & Aziz, M. (2019). Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study. The Lancet HIV, 6(9), e601-e612.en_US
dc.identifier.issn2352-3018
dc.identifier.pmid31498109
dc.identifier.doi10.1016/S2352-3018(19)30155-9
dc.identifier.urihttp://hdl.handle.net/10150/635046
dc.description.abstractWe did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016. We enrolled women with HIV who were either ART-naive (control group; n=25), receiving efavirenz-based ART (n=25), or receiving atazanavir-ritonavir-based ART (n=24). Women receiving ART were required to be on the same regimen for at least 30 days, with 400 copies or less per mL of plasma HIV-1 RNA; women not receiving ART had CD4 counts of 350 cells per μL or less. We excluded participants who had a bilateral oophorectomy or conditions that were contraindicated in the intravaginal ring product labelling. An intravaginal ring releasing etonogestrel and ethinylestradiol was inserted at entry (day 0). Single plasma samples for hormone concentrations were collected on days 7, 14, and 21 after intravaginal ring insertion. The primary outcome was the plasma concentration of etonogestrel and ethinylestradiol on day 21. Etonogestrel and ethinylestradiol concentrations were compared between each ART group and the control group by geometric mean ratio (GMR) with 90% CIs and Wilcoxon rank-sum test. As secondary outcomes, efavirenz or ritonavir-boosted atazanavir concentrations were assessed by 8-h intensive pharmacokinetic sampling at entry before intravaginal ring insertion and before intravaginal ring removal on day 21. Antiretroviral areas under the concentration-time curve (AUC0-8 h) were compared before and after intravaginal ring insertion by GMR (90% CI) and Wilcoxon signed-rank test. This study is registered with ClinicalTrials.gov, number NCT01903031.en_US
dc.description.sponsorshipNational Institutes of Health, through the AIDS Clinical Trials GroupUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USA; National Institutes of Health, through the International Maternal Pediatric Adolescent AIDS Clinical Trials NetworkUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USA; National Institute of Allergy and Infectious DiseasesUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute of Allergy & Infectious Diseases (NIAID); National Institute of Mental HealthUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute of Mental Health (NIMH); Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)en_US
dc.language.isoenen_US
dc.publisherELSEVIER INCen_US
dc.rightsCopyright © 2019 Elsevier Ltden_US
dc.titleAntiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic studyen_US
dc.typeArticleen_US
dc.contributor.departmentUniv Arizonaen_US
dc.identifier.journalLANCET HIVen_US
dc.description.note6 month embargo; published online: 4 September 2019en_US
dc.description.collectioninformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.en_US
dc.eprint.versionFinal accepted manuscripten_US
dc.source.journaltitleThe lancet. HIV


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