Evidence map›Paper›PMID 31194965›Full record

Trial reportContraception2019

Effects of ritonavir-boosted protease inhibitors on combined oral contraceptive pharmacokinetics and pharmacodynamics in HIV-positive women.

Teresa Barcellos, Melissa Natavio, Frank Z Stanczyk, Dandan Luo, William J Jusko, Nicole M Bender

Open access · greenAbstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contraception, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Oral Drugs Against COVID-19.Deutsches Arzteblatt international · 2022
    Article
  4. Article
  5. Review
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

6 authors at 2 institutions in 1 country.

Teresa BarcellosDepartment of Obstetrics and Gynecology, Keck School of Medicine of University of Southern California, Los Angeles, CA 90033, USA. Electronic address: tbarcellos@allcare-med.com.
Melissa NatavioDepartment of Obstetrics and Gynecology, Keck School of Medicine of University of Southern California, Los Angeles, CA 90033, USA.
Frank Z StanczykDepartment of Obstetrics and Gynecology, Keck School of Medicine of University of Southern California, Los Angeles, CA 90033, USA.
Dandan LuoDepartment of Biomedical Engineering, University at Buffalo, State University of New York, Buffalo, NY 14260, USA; Department of Pharmaceutical Sciences, University at Buffalo, State University of New York, Buffalo, NY 14214, USA.
William J JuskoDepartment of Pharmaceutical Sciences, University at Buffalo, State University of New York, Buffalo, NY 14214, USA.
Nicole M BenderDepartment of Obstetrics and Gynecology, Keck School of Medicine of University of Southern California, Los Angeles, CA 90033, USA.
University of Southern California · USUniversity at Buffalo, State University of New York · US

Funding

Corticosteroid Pharmacokinetics and PharmacodynamicsR37GM024211 · NIGMS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI JUSKO, WILLIAM J. · 2005 to 2014
$6.4M
CORTICOSTEROID PHARMACOKINETICS/DYNAMICSR01GM024211 · NIGMS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI JUSKO, WILLIAM J. · 1985 to 2018
$4.7M
NIGMS NIH HHS R01 GM024211NIGMS NIH HHS R37 GM024211
6 · The paper itself

Abstract

objectiveTo assess the pharmacokinetics of combined oral contraceptive (COC) components and prevalence of ovulation in HIV-positive women using ritonavir-containing antiretroviral regimens compared to those using regimens previously found not to interact with COCs or not using any antiretrovirals. STUDY

designWe conducted a prospective cohort pharmacokinetic pilot study comparing the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE) in HIV-positive women taking ritonavir-containing antiretroviral regimens to those in women using non-ritonavir-containing regimens or no antiretrovirals. Participants received COCs containing LNG/EE 150/30 mcg for 21 days. Beginning day 21, we collected serial blood samples over 72 h. The primary outcome was area under the curve (AUC) of LNG, with secondary outcomes including other LNG pharmacokinetic measures, EE pharmacokinetics and ovulation as measured by serum progesterone.

resultsPharmacokinetic parameters of LNG showed a trend toward increased exposure in women on ritonavir. LNG AUC

conclusionWomen on ritonavir showed an approximately 30% increase in LNG exposure but no difference in EE exposure. IMPLICATIONS: The current data suggest that ritonavir does not have a clinically significant impact on oral contraceptive pharmacokinetics.

Indexed as

AdultArea Under CurveCaliforniaContraceptives, Oral, CombinedDrug CombinationsDrug InteractionsEthinyl EstradiolFemaleHIV Protease InhibitorsHIV SeropositivityHumansLevonorgestrelProgesteroneRitonavirContraceptives, Oral, CombinedDrug CombinationsEthinyl Estradiolethinyl estradiol, levonorgestrel drug combinationHIV Protease InhibitorsLevonorgestrelProgesteroneRitonavirClearanceCombined oral contraceptivesHIV-positivePharmacokineticsVolume of distribution

Identifiers

PMID31194965
PMCPMC6778019
OpenAlexW2952269125

What OpenQuestion holds

Textmetadata
LicenceTDM
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.