ArticleAntimicrobial agents and chemotherapy2014
Pharmacokinetics and preliminary safety study of pod-intravaginal rings delivering antiretroviral combinations for HIV prophylaxis in a macaque model.
Article in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The experience of healthcare workers to HIV pre-exposure prophylaxis (PrEP) implementation in low- and middle-income countries: a systematic review and qualitative meta-synthesis.Frontiers in public health · 2023Pooled it
- Dose-ranging pharmacokinetics, safety, and efficacy of a 90-day intravaginal ring delivering islatravir in pigtail macaques.Science advances · 2026Article
- Preclinical Pharmacokinetics of a Triple-Combination Intravaginal Ring for HIV Prevention.Pharmaceutics · 2026Article
- Development and characterization of formulations based on combinatorial potential of antivirals against genital herpes.Naunyn-Schmiedeberg's archives of pharmacology · 2025Article
- Preclinical validation of electrospun fibers to achieve vaginal colonization byFrontiers in bacteriology · 2025Article
- Next-generation 3D printed multipurpose prevention intravaginal ring for prevention of HIV, HSV-2, and unintended pregnancy.Journal of controlled release : official journal of the Controlled Release Society · 2024Article
- Long-acting injectable multipurpose prevention technology for prevention of HIV and unplanned pregnancy.Journal of controlled release : official journal of the Controlled Release Society · 2023Article
- An optimized Factor H-Fc fusion protein against multidrug-resistantFrontiers in immunology · 2022Article
- Multipurpose Prevention Technologies: Oral, Parenteral, and Vaginal Dosage Forms for Prevention of HIV/STIs and Unplanned Pregnancy.Polymers · 2021Review
- In Vitro Methods for Evaluating Drug Release of Vaginal Ring Formulations-A Critical Review.Pharmaceutics · 2019Review
- Rational Development of Liposomal Hydrogels: A Strategy for Topical Vaginal Antiretroviral Drug Delivery in the Context of HIV Prevention.Pharmaceutics · 2019Article
- Vaginal rings with exposed cores for sustained delivery of the HIV CCR5 inhibitor 5P12-RANTES.Journal of controlled release : official journal of the Controlled Release Society · 2019Article
- Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.PLoS medicine · 2018Article
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- Pharmacokinetics and Preliminary Safety of Pod-Intravaginal Rings Delivering the Monoclonal Antibody VRC01-N for HIV Prophylaxis in a Macaque Model.Antimicrobial agents and chemotherapy · 2017Article
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- Article
- Development of peptide inhibitors of HIV transmission.Bioactive materials · 2016Review
- Nonhuman primate models for the evaluation of HIV-1 preventive vaccine strategies: model parameter considerations and consequences.Current opinion in HIV and AIDS · 2016Review
- Safety and Pharmacokinetics of Quick-Dissolving Polymeric Vaginal Films Delivering the Antiretroviral IQP-0528 for Preexposure Prophylaxis.Antimicrobial agents and chemotherapy · 2016Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
Preexposure prophylaxis using oral regimens involving the HIV nucleoside reverse transcriptase inhibitors tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) demonstrated efficacy in three clinical trials. Adherence was determined to be a key parameter for success. Incorporation of the TDF-FTC combination into intravaginal rings (IVRs) for sustained mucosal delivery could increase product adherence and efficacy compared with those of oral and vaginal gel formulations. A novel pod-IVR technology capable of delivering multiple drugs is described; this constitutes the first report of an IVR delivering TDF and FTC, as well as a triple-combination IVR delivering TDF, FTC, and the entry inhibitor maraviroc (MVC). The pharmacokinetics and preliminary local safety of the two combination pod-IVRs were evaluated in the pig-tailed macaque model. The devices exhibited sustained release at controlled rates over the 28-day study period. Median steady-state drug levels in vaginal tissues in the TDF-FTC group were 30 μg g(-1) (tenofovir [TFV], in vivo hydrolysis product of TDF) and 500 μg g(-1) (FTC) and in the TDF-FTC-MVC group were 10 μg g(-1) (TFV), 150 μg g(-1) (FTC), and 20 μg g(-1) (MVC). No adverse events were observed, and there were no toxicological findings. Mild-to-moderate increases in inflammatory infiltrates were observed in the vaginal tissues of some animals in both the presence and the absence of the IVRs. The IVRs did not disturb the vaginal microbiota, and levels of proinflammatory cytokines remained stable throughout the study. Pod-IVR candidates based on the TDF-FTC combination have potential for the prevention of vaginal HIV acquisition and merit clinical investigation.
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