Evidence map›Paper›PMID 27139475›Full record

ArticleAntimicrobial agents and chemotherapy2016

Safety and Pharmacokinetics of Quick-Dissolving Polymeric Vaginal Films Delivering the Antiretroviral IQP-0528 for Preexposure Prophylaxis.

Priya Srinivasan, Jining Zhang, Amy Martin, Kristin Kelley, Janet M McNicholl, Robert W Buckheit, James M Smith, Anthony S Ham

Open access · bronzeAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

13 citing papers in PubMed, 29 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. Article
  6. Review
  7. Review
  8. 20S Proteasome as a Drug Target in Trichomonas vaginalis.Antimicrobial agents and chemotherapy · 2019
    Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Nanoparticle Encapsulation for Antiretroviral Pre-Exposure Prophylaxis.Journal of nanotechnology and materials science · 2017
    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

8 authors at 3 institutions in 1 country.

Priya SrinivasanCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Jining ZhangTotal Solutions, Inc., Atlanta, Georgia, USA.
Amy MartinCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Kristin KelleyMcNeal Professionals, Atlanta, Georgia, USA.
Janet M McNichollCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Robert W BuckheitImQuest BioSciences, Inc., Fredrick, Maryland, USA.
James M SmithCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Anthony S HamImQuest BioSciences, Inc., Fredrick, Maryland, USA aham@imquestbio.com.
Centers for Disease Control and Prevention · USImQuest BioSciences (United States) · USTotal (United States) · US

Funding

Development of a novel nanoparticle pyrimidinedione vaginal polymeric film as anR33AI088586 · NIAID · IMQUEST BIOSCIENCES · PI HAM, ANTHONY SANG WON · 2012 to 2014
$1.1M
NIAID NIH HHS R33 AI088586
6 · The paper itself

Abstract

For human immunodeficiency virus (HIV) prevention, microbicides or drugs delivered as quick-dissolving films may be more acceptable to women than gels because of their compact size, minimal waste, lack of an applicator, and easier storage and transport. This has the potential to improve adherence to promising products for preexposure prophylaxis. Vaginal films containing IQP-0528, a nonnucleoside reverse transcriptase inhibitor, were evaluated for their pharmacokinetics in pigtailed macaques. Polymeric films (22 by 44 by 0.1 mm; providing 75% of a human dose) containing IQP-0528 (1.5%, wt/wt) with and without poly(lactic-co-glycolic acid) (PLGA) nanoparticle encapsulation were inserted vaginally into pigtailed macaques in a crossover study design (n = 6). With unencapsulated drug, the median (range) vaginal fluid concentrations of IQP-0528 were 160.97 (2.73 to 2,104), 181.79 (1.86 to 15,800), and 484.50 (8.26 to 4,045) μg/ml at 1, 4, and 24 h after film application, respectively. Median vaginal tissue IQP-0528 concentrations at 24 h were 3.10 (0.03 to 222.58) μg/g. The values were similar at locations proximal, medial, and distal to the cervix. The IQP-0528 nanoparticle-formulated films delivered IQP-0528 in vaginal tissue and secretions at levels similar to those obtained with the unencapsulated formulation. A single application of either formulation did not disturb the vaginal microflora or the pH (7.24 ± 0.84 [mean ± standard deviation]). The high mucosal IQP-0528 levels delivered by both vaginal film formulations were between 1 and 5 log higher than the in vitro 90% inhibitory concentration (IC90) of 0.146 μg/ml. The excellent coverage and high mucosal levels of IQP-0528, well above the IC90, suggest that the films may be protective and warrant further evaluation in a vaginal repeated low dose simian-human immunodeficiency virus (SHIV) transmission study in macaques and clinically in women.

Indexed as

Administration, IntravaginalAnimalsAnti-HIV AgentsFemaleHIV-1HIV InfectionsLactic AcidMacaca nemestrinaPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerPyrimidinonesVaginaAnti-HIV AgentsIQP-0528Lactic AcidPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerPyrimidinones

Identifiers

PMID27139475
PMCPMC4914618
OpenAlexW2346075009

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.