Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study
AuthorScarsi, Kimberly K
Cramer, Yoninah S
Rosenkranz, Susan L
Coombs, Robert W
Moran, Laura E
Zorrilla, Carmen D
Friedman, Ruth K
Cohn, Susan E
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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.
RightsCopyright © 2019 Elsevier Ltd
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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.
Note6 month embargo; published online: 4 September 2019
VersionFinal accepted manuscript
SponsorsNational 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)