ArticlePloS one2016
Topical Delivery of Tenofovir Disoproxil Fumarate and Emtricitabine from Pod-Intravaginal Rings Protects Macaques from Multiple SHIV Exposures.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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
19 citing papers in PubMed, 30 citations in OpenAlex.
- Comparison of the Pharmacokinetics and Pharmacodynamics of Single-Dose Tenofovir Vaginal Film and Gel Formulation (FAME 05).Journal of acquired immune deficiency syndromes (1999) · 2018Trial
- 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
- Acute antagonism in three-drug combinations for vaginal HIV prevention in humanized mice.Scientific reports · 2023Article
- Manufacturing and Examination of Vaginal Drug Delivery System by FDM 3D Printing.Pharmaceutics · 2021Article
- A Summary of the Fifth Annual Virology Education HIV Microbiome Workshop.AIDS research and human retroviruses · 2020Article
- 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
- Making the case: developing innovative adherence solutions for the treatment of tuberculosis.BMJ global health · 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
- An intravaginal ring that releases three antiviral agents and a contraceptive blocks SHIV-RT infection, reduces HSV-2 shedding, and suppresses hormonal cycling in rhesus macaques.Drug delivery and translational research · 2017Article
- Repeated administration of high-dose depot medroxyprogesterone acetate does not alter SHIVJournal of medical primatology · 2017Article
- 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
- Prevention of vaginal and rectal HIV transmission by antiretroviral combinations in humanized mice.PloS one · 2017Article
- Article
- Combination Pod-Intravaginal Ring Delivers Antiretroviral Agents for HIV Prophylaxis: Pharmacokinetic Evaluation in an Ovine Model.Antimicrobial agents and chemotherapy · 2016Article
- Are you PEPped and PrEPped for travel? Risk mitigation of HIV infection for travelers.Tropical diseases, travel medicine and vaccines · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Topical preexposure prophylaxis (PrEP) against HIV has been marginally successful in recent clinical trials with low adherence rates being a primary factor for failure. Controlled, sustained release of antiretroviral (ARV) drugs may help overcome these low adherence rates if the product is protective for extended periods of time. The oral combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is currently the only FDA-approved ARV drug for HIV PrEP. A novel pod-intravaginal ring (IVR) delivering TDF and FTC at independently controlled rates was evaluated for efficacy at preventing SHIV162p3 infection in a rigorous, repeat low-dose vaginal exposure model using normally cycling female pigtailed macaques. Six macaques received pod-IVRs containing TDF (65 mg) and FTC (68 mg) every two weeks, and weekly vaginal exposures to 50 TCID50 of SHIV162p3 began one week after the first pod-IVR insertion. All pod-IVR-treated macaques were fully protected throughout the study (P = 0.0002, Log-rank test), whereas all control animals became infected with a median of 4 exposures to infection. The topical, sustained release of TDF and FTC from the pod-IVR maintained protective drug levels in macaques over four months of virus exposures. This novel and versatile delivery system has the capacity to deliver and maintain protective levels of multiple drugs and the protection observed here warrants clinical evaluation of this pod-IVR design.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.