ArticleScience advances2026
Dose-ranging pharmacokinetics, safety, and efficacy of a 90-day intravaginal ring delivering islatravir in pigtail macaques.
Priya Srinivasan, Jasmine L King, Jining Zhang, Isabella C Young, Dawn Little, Mackenzie L Cottrell, Craig Sykes, Amanda P Schauer, James Mitchell, Angela D M Kashuba and 3 more
Abstract read
In one paragraphArticle in Science advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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2 · The registryThe trial behind it
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5 · Who and what moneyAuthors and funding
13 authors.
Priya SrinivasanLaboratory Branch, Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0000-0001-8426-6532 Jasmine L KingLampe Joint Department of Biomedical Engineering, North Carolina State University and The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-8986-6868 Jining ZhangLaboratory Branch, Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0009-0007-9213-4178 Isabella C YoungDivision of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Mackenzie L CottrellDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Craig SykesDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Amanda P SchauerDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-7026-7224 James MitchellLaboratory Branch, Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0009-0000-9916-3325 Angela D M KashubaDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-9171-8493 J Gerardo García-LermaLaboratory Branch, Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0000-0001-6437-7745 Soumya Rahima BenhabbourLampe Joint Department of Biomedical Engineering, North Carolina State University and The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-4738-5871 James M SmithLaboratory Branch, Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0000-0002-4221-9858 Funding
Next Generation Multipurpose Intravaginal Ring Technology Using Innovative CLIP 3D PrintingR01AI150358 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BENHABBOUR, SOUMYA RAHIMA · 2020 to 2024
$4.1MBAA-CLIN TRIALS &CLIN MARKERS FOR IMMUNOLOGIC DISEASESN01AI005410 · NIAID · CASE WESTERN RESERVE UNIVERSITY · 2000 to 2002
$709kNIAID NIH HHS N01 AI005410NIAID NIH HHS R01 AI150358
6 · The paper itselfAbstract
Intravaginal rings (IVRs) are attractive user-controlled delivery systems that can achieve sustained release of compounds for several weeks. We modeled in macaques a three-dimensional (3D)-printed IVR delivering the investigational nucleoside reverse transcriptase translocator inhibitor islatravir (ISL). Three IVRs with 15, 30, or 60 milligrams of ISL were used in 30-day pharmacokinetic and safety studies followed by 90-day studies to identify a dose that maintains the concentration of the active intracellular metabolite islatravir triphosphate (ISL-TP) above protective benchmarks. IVRs were safe and delivered ISL in a dose-dependent manner. In a challenge study involving 12 weekly low-dose vaginal exposures to SHIV162p3, six macaques treated with 60-milligram ISL IVRs for 90 days remained seronegative and SHIV RNA negative, while two untreated controls were infected. These data provide initial preclinical evidence that a 90-day extended-release ISL IVR is safe and offers complete protection in a stringent challenge model, warranting further clinical investigation.
Indexed as
Contraceptive Devices, FemaleSimian Acquired Immunodeficiency SyndromeAdministration, IntravaginalAnimalsDeoxyadenosinesDose-Response Relationship, DrugFemaleMacaca nemestrinaSimian Immunodeficiency VirusDeoxyadenosinesislatravir
Identifiers
PMID42647641
PMCPMC13510676
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