Evidence map›Paper›PMID 25624326›Full record

Trial reportAntimicrobial agents and chemotherapy2015

Depot medroxyprogesterone acetate in combination with a twice-daily lopinavir-ritonavir-based regimen in HIV-infected women showed effective contraception and a lack of clinically significant interactions, with good safety and tolerability: results of the ACTG 5283 study.

Amneris E Luque, Susan E Cohn, Jeong-Gun Park, Yoninah Cramer, Adriana Weinberg, Elizabeth Livingston, Karin L Klingman, Francesca Aweeka, D Heather Watts

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01296152 (An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% 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.

NCT01296152 phase2completednot on this map

An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA) and Lopinavir/Ritonavir (LPV/r) and of the Effects of DMPA on Cellular Immunity and Regulation in HIV-Infected Women

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2011 to 2012Enrolled25ConditionsHIV-1 InfectionArmsdepo-medroxyprogesterone acetate
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. U.S. Medical Eligibility Criteria for Contraceptive Use, 2024.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2024
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. 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

9 authors at 8 institutions in 1 country.

Amneris E LuqueUniversity of Rochester School of Medicine and Dentistry, Rochester, New York, USA amneris_luque@urmc.rochester.edu.
Susan E CohnNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Jeong-Gun ParkStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, USA.
Yoninah CramerStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, USA.
Adriana WeinbergUniversity of Colorado Denver, Aurora, Colorado, USA.
Elizabeth LivingstonDuke University Medical Center, Durham, North Carolina, USA.
Karin L KlingmanDivision of AIDS, National Institutes of Health, Bethesda, Maryland, USA.
Francesca AweekaUniversity of California, San Francisco, California, USA.
D Heather WattsOffice of the Global AIDS Coordinator, U.S. Department of State, Washington, DC, USA.
Harvard University · USDuke Medical Center · USNational Institutes of Health · USNorthwestern University · USUnited States Department of State · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Rochester · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 1988 to 2026
$93.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
NCATS NIH HHS 1UL1TR001111NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1TR000150NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NCRR NIH HHS UL-1RR02460NIAID NIH HHS 1U01AI068636NIAID NIH HHS 1U01AI069471NIAID NIH HHS 1U01AI069481NIAID NIH HHS 1U01AI069511NIAID NIH HHS 1U01AI069513NIAID NIH HHS AI068634NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI50410NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069481NIAID NIH HHS U01 AI069511NIAID NIH HHS U01 AI069513NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1-AI069423-08NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI106716NIAID NIH HHS UM1AI106716
6 · The paper itself

Abstract

We conducted an open-label, steady-state pharmacokinetic (PK) study of drug-drug interactions between depot medroxyprogesterone acetate (DMPA) and twice-daily lopinavir (LPV) plus low-dose ritonavir (RTV) (LPV/r) among 24 HIV-infected women and compared the results to those for HIV-infected women receiving DMPA while on no antiretroviral therapy or on nucleosides only (n = 14 subjects from the control arm of AIDS Clinical Trials Group [ACTG] study 5093). The objectives of the study were to address the effect of LPV/r on DMPA and to address the effect of DMPA on LPV/r therapy. PK parameters were estimated using noncompartmental analysis with between-group comparisons of medroxyprogesterone acetate (MPA) PKs and within-subject comparisons of LPV and RTV PKs before and 4 weeks after DMPA dosing. Plasma progesterone concentrations were measured every 2 weeks after DMPA dosing through week 12. Although the MPA area under the concentration-time curve and maximum concentration of drug in plasma were statistically significantly increased in the study women on LPV/r compared to those in the historical controls, these increases were not considered clinically significant. There were no changes in LPV or RTV exposure after DMPA. DMPA was well tolerated, and suppression of ovulation was maintained. (This study has been registered at ClinicalTrials.gov under registration no. NCT01296152.).

Indexed as

AdolescentContraceptives, Oral, SyntheticDelayed-Action PreparationsDrug InteractionsFemaleHIV InfectionsHIV Protease InhibitorsHumansLopinavirMedroxyprogesterone AcetateMiddle AgedOvulationProgesteroneRitonavirYoung AdultContraceptives, Oral, SyntheticDelayed-Action PreparationsHIV Protease InhibitorsLopinavirMedroxyprogesterone AcetateProgesteroneRitonavir

Identifiers

PMID25624326
PMCPMC4356823
OpenAlexW2048421066

What Socratic holds

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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 Socratic graph.