Evidence map›Paper›PMID 22964245›Full record

ArticleAntimicrobial agents and chemotherapy2012

Safety and pharmacokinetics of intravaginal rings delivering tenofovir in pig-tailed macaques.

John A Moss, Amanda M Malone, Thomas J Smith, Irina Butkyavichene, Cassandra Cortez, Joshua Gilman, Sean Kennedy, Etana Kopin, Cali Nguyen, Preetha Sinha and 10 more

Open access · bronzeAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

36 citing papers in PubMed, 45 citations in OpenAlex.

  1. Article
  2. Article
  3. 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
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. 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
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Accurate measurement of female genital tract fluid dilution in cervicovaginal lavage samples.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2016
    Article
  19. Article
  20. 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

20 authors at 4 institutions in 1 country.

John A MossDepartment of Chemistry, Oak Crest Institute of Science, Pasadena, California, USA.
Amanda M Malone
Thomas J Smith
Irina Butkyavichene
Cassandra Cortez
Joshua Gilman
Sean Kennedy
Etana Kopin
Cali Nguyen
Preetha Sinha
R Michael Hendry
Patricia Guenthner
Angela Holder
Amy Martin
Janet McNicholl
James Mitchell
Chou-Pong Pau
Priya Srinivasan
James M Smith
Marc M Baum
Oak Crest Institute of Science · USNational Center for HIV/AIDS Viral Hepatitis STD and TB Prevention · USAuritec Pharmaceuticals (United States) · USCenters for Disease Control and Prevention · US

Funding

Intravaginal ring microbicide formulations comprising multiple anti-HIV agentsR21AI079791 · NIAID · OAK CREST INSTITUTE OF SCIENCE · PI SMITH, THOMAS J. · 2008 to 2009
$419k
Vaginal ring formulation of tenofovir microbicideR21AI076136 · NIAID · OAK CREST INSTITUTE OF SCIENCE · PI SMITH, THOMAS J. · 2009 to 2010
$411k
DETERMINATION OF GENETIC LOCI OF DENGUE TYPE 2 VIRUS NEUROVIRULENCE IN MICEZ01AI000681 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI LAI, C-J · 1994 to 1996
–
NIAID NIH HHS 5R21AI076136NIAID NIH HHS 5R21AI079791NIAID NIH HHS R21 AI076136NIAID NIH HHS R21 AI079791NIAID NIH HHS Y01 AI000681
6 · The paper itself

Abstract

Antiretroviral-based microbicides applied topically to the vagina may play an important role in protecting women from HIV infection. Incorporation of the nucleoside reverse transcriptase inhibitor tenofovir (TFV) into intravaginal rings (IVRs) for sustained mucosal delivery may lead to increased microbicide product adherence and efficacy compared with those of conventional vaginal formulations. Formulations of a novel "pod IVR" platform spanning a range of IVR drug loadings and daily release rates of TFV were evaluated in a pig-tailed macaque model. The rings were safe and exhibited sustained release at controlled rates over 28 days. Vaginal secretion TFV levels were independent of IVR drug loading and were able to be varied over 1.5 log units by changing the ring configuration. Mean TFV levels in vaginal secretions were 72.4 ± 109 μg ml(-1) (slow releasing) and 1.84 ± 1.97 mg ml(-1) (fast releasing). The mean TFV vaginal tissue concentration from the slow-releasing IVRs was 76.4 ± 54.8 μg g(-1) and remained at steady state 7 days after IVR removal, consistent with the long intracellular half-life of TFV. Intracellular tenofovir diphosphate (TFV-DP), the active moiety in defining efficacy, was measured in vaginal lymphocytes collected in the study using the fast-releasing IVR formulation. Mean intracellular TFV-DP levels of 446 ± 150 fmol/10(6) cells fall within a range that may be protective of simian-human immunodeficiency virus strain SF162p3 (SHIV(SF162p3)) infection in nonhuman primates. These data suggest that TFV-releasing IVRs based on the pod design have potential for the prevention of transmission of human immunodeficiency virus type 1 (HIV-1) and merit further clinical investigation.

Indexed as

AdenineAdministration, IntravaginalAnimalsContraceptive Devices, FemaleCytokinesDelayed-Action PreparationsFemaleHalf-LifeLymphocytesMacaca nemestrinaOrganophosphonatesReverse Transcriptase InhibitorsTenofovirVaginaAdenineCytokinesDelayed-Action PreparationsOrganophosphonatesReverse Transcriptase InhibitorsTenofovir

Identifiers

PMID22964245
PMCPMC3486594
OpenAlexW2143206856

What OpenQuestion holds

Textmetadata
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.