Evidence map›Paper›PMID 28982161›Full record

ArticlePloS one2017

Novel multipurpose pod-intravaginal ring for the prevention of HIV, HSV, and unintended pregnancy: Pharmacokinetic evaluation in a macaque model.

James M Smith, John A Moss, Priya Srinivasan, Irina Butkyavichene, Manjula Gunawardana, Rob Fanter, Christine S Miller, Debbie Sanchez, Flora Yang, Shanon Ellis and 5 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 34 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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 · 2024
    Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. 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 · 2019
    Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

James M SmithLaboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
John A MossDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Priya SrinivasanLaboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Irina ButkyavicheneDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Manjula GunawardanaDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Rob FanterDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Christine S MillerDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Debbie SanchezDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Flora YangDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.
Shanon EllisLibra Management Group, Decatur, Georgia, United States of America.
Jining ZhangLibra Management Group, Decatur, Georgia, United States of America.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, Osler, Baltimore, Maryland, United States of America.
Craig W HendrixDepartment of Medicine, Johns Hopkins University, Osler, Baltimore, Maryland, United States of America.
Amita KapoorWisconsin National Primate Research Center, University of Wisconsin-Madison, Capitol Court, Madison, Wisconsin, United States of America.
Marc M BaumDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, California, United States of America.ORCID http://orcid.org/0000-0003-1558-5649
Oak Crest Institute of Science · USAlibaba Group (United States) · USCenters for Disease Control and Prevention · USJohns Hopkins University · USUniversity of Wisconsin–Madison · US

Funding

Systematic Development of Antiretroviral Intravaginal Rings for HIV PreventionU19AI113048 · NIAID · OAK CREST INSTITUTE OF SCIENCE · PI VINCENT, KATHLEEN LISTIAK · 2014 to 2018
$18.4M
NIAID NIH HHS U19 AI113048
6 · The paper itself

Abstract

Globally, women bear an uneven burden for sexual HIV acquisition. Results from two clinical trials evaluating intravaginal rings (IVRs) delivering the antiretroviral agent dapivirine have shown that protection from HIV infection can be achieved with this modality, but high adherence is essential. Multipurpose prevention technologies (MPTs) can potentially increase product adherence by offering protection against multiple vaginally transmitted infections and unintended pregnancy. Here we describe a coitally independent, long-acting pod-IVR MPT that could potentially prevent HIV and HSV infection as well as unintended pregnancy. The pharmacokinetics of MPT pod-IVRs delivering tenofovir alafenamide hemifumarate (TAF2) to prevent HIV, acyclovir (ACV) to prevent HSV, and etonogestrel (ENG) in combination with ethinyl estradiol (EE), FDA-approved hormonal contraceptives, were evaluated in pigtailed macaques (N = 6) over 35 days. Pod IVRs were exchanged at 14 days with the only modification being lower ENG release rates in the second IVR. Plasma progesterone was monitored weekly to determine the effect of ENG/EE on menstrual cycle. The mean in vivo release rates (mg d-1) for the two formulations over 30 days ranged as follows: TAF2 0.35-0.40; ACV 0.56-0.70; EE 0.03-0.08; ENG (high releasing) 0.63; and ENG (low releasing) 0.05. Mean peak progesterone levels were 4.4 ± 1.8 ng mL-1 prior to IVR insertion and 0.075 ± 0.064 ng mL-1 for 5 weeks after insertion, suggesting that systemic EE/ENG levels were sufficient to suppress menstruation. The TAF2 and ACV release rates and resulting vaginal tissue drug concentrations (medians: TFV, 2.4 ng mg-1; ACV, 0.2 ng mg-1) may be sufficient to protect against HIV and HSV infection, respectively. This proof of principle study demonstrates that MPT-pod IVRs could serve as a potent biomedical prevention tool to protect women's sexual and reproductive health and may increase adherence to HIV PrEP even among younger high-risk populations.

Indexed as

Contraceptive Devices, FemalePregnancy, UnplannedAdministration, IntravaginalAnimalsAntiviral AgentsFemaleHerpes GenitalisHIV InfectionsHumansMacaca nemestrinaPregnancyAntiviral Agents

Identifiers

PMID28982161
PMCPMC5628903
OpenAlexW2761054444

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

Registered trials

None linked

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.