Evidence map›Paper›PMID 26082504›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Efavirenz Pharmacokinetics and Pharmacodynamics in HIV-Infected Persons Receiving Rifapentine and Isoniazid for Tuberculosis Prevention.

Anthony T Podany, Yajing Bao, Susan Swindells, Richard E Chaisson, Janet W Andersen, Thando Mwelase, Khuanchai Supparatpinyo, Lerato Mohapi, Amita Gupta, Constance A Benson and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03934931 (Options for Delivering Isoniazid-Rifapentine), which is not on this map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT03934931 nacompletednot on this mapstarted 2020, after this paper: background citation

Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2025Enrolled1,656ConditionsTuberculosis, Latent Tuberculosis, HIV/AIDSArmsStreamlined weekly DOT visits, Weekly DOT visit reminders, Cost reimbursement DOT, 99DOTS, Weekly SAT dosing reminders/check-ins
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Twice-Daily Dolutegravir-Based Antiretroviral Therapy With 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis Prevention.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  12. Trial
  13. Article
  14. Article
  15. US Guidelines Fall Short on Short-Course Tuberculosis-Preventive Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  16. An Overview of Various Rifampicin Analogs againstMedicinal chemistry (Shariqah (United Arab Emirates)) · 2024
    Review
  17. Article
  18. Review
  19. New and Repurposed Drugs for the Treatment of Active Tuberculosis: An Update for Clinicians.Respiration; international review of thoracic diseases · 2023
    Review
  20. Potential Impact of Long-Acting Products on the Control of Tuberculosis: Preclinical Advancements and Translational Tools in Preventive Treatment.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    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

13 authors at 8 institutions in 3 countries.

Anthony T PodanyCollege of Pharmacy, University of Nebraska Medical Center, Omaha.
Yajing BaoStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
Susan SwindellsInfectious Diseases, Internal Medicine, University of Nebraska Medical Center, Omaha.
Richard E ChaissonCenter for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Janet W AndersenStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
Thando MwelaseUniversity of the Witwatersrand, Johannesburg, South Africa.
Khuanchai SupparatpinyoResearch Institute for Health Sciences and Faculty of Medicine, Chiang Mai University, Thailand.
Lerato MohapiUniversity of the Witwatersrand and Baragwanath Hospital, Soweto, South Africa.
Amita GuptaCenter for Clinical Global Health Education, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Constance A BensonAntiviral Research Center, University of California, San Diego.
Peter KimDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Courtney V FletcherCollege of Pharmacy, University of Nebraska Medical Center, Omaha Infectious Diseases, Internal Medicine, University of Nebraska Medical Center, Omaha.
AIDS Clinical Trials Group A5279 Study Team
University of Nebraska Medical Center · USHarvard University · USUniversity of the Witwatersrand · ZAChiang Mai University · THJohns Hopkins Medicine · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USUniversity of California, San Diego · 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 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
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
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
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
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
THE IMPACTA PERU CLINICAL TRIALS UNITUM1AI069438 · NIAID · ASOCIACION CIVIL IMPACTA SALUD Y EDUCACN · PI Alberto La Rosa, Jorge Luis Sanchez · 2012 to 2026
$43.2M
NIAID NIH HHS P30 AI094189NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069438NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069477NIAID NIH HHS U01 AI069481NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069438NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069477NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM AI069423
6 · The paper itself

Abstract

backgroundConcomitant use of rifamycins to treat or prevent tuberculosis can result in subtherapeutic concentrations of antiretroviral drugs. We studied the interaction of efavirenz with daily rifapentine and isoniazid in human immunodeficiency virus (HIV)-infected individuals receiving a 4-week regimen to prevent tuberculosis.

methodsParticipants receiving daily rifapentine and isoniazid with efavirenz had pharmacokinetic evaluations at baseline and weeks 2 and 4 of concomitant therapy. Efavirenz apparent oral clearance was estimated and the geometric mean ratio (GMR) of values before and during rifapentine and isoniazid was calculated. HIV type 1 (HIV-1) RNA was measured at baseline and week 8.

resultsEighty-seven participants were evaluable: 54% were female, and the median age was 35 years (interquartile range [IQR], 29-44 years). Numbers of participants with efavirenz concentrations ≥1 mg/L were 85 (98%) at week 0; 81 (93%) at week 2; 78 (90%) at week 4; and 75 (86%) at weeks 2 and 4. Median efavirenz apparent oral clearance was 9.3 L/hour (IQR, 6.42-13.22 L/hour) at baseline and 9.8 L/hour (IQR, 7.04-15.59 L/hour) during rifapentine/isoniazid treatment (GMR, 1.04 [90% confidence interval, .97-1.13]). Seventy-nine of 85 (93%) participants had undetectable HIV-1 RNA (<40 copies/mL) at entry; 71 of 75 (95%) participants had undetectable HIV-1 RNA at week 8. Two participants with undetectable HIV-1 RNA at study entry were detectable (43 and 47 copies/mL) at week 8.

conclusionsThe proportion of participants with midinterval efavirenz concentrations ≥1 mg/L did not cross below the prespecified threshold of >80%, and virologic suppression was maintained. Four weeks of daily rifapentine plus isoniazid can be coadministered with efavirenz without clinically meaningful reductions in efavirenz mid-dosing concentrations or virologic suppression. CLINICAL TRIALS REGISTRATION: NCT 01404312.

Indexed as

Administration, OralAdultAlkynesAnti-HIV AgentsAntitubercular AgentsBenzoxazinesCyclopropanesDrug Therapy, CombinationFemaleHIV-1HIV InfectionsHumansIsoniazidMaleReverse Transcriptase InhibitorsRifampinAlkynesAnti-HIV AgentsAntitubercular AgentsBenzoxazinesCyclopropanesefavirenzIsoniazidReverse Transcriptase InhibitorsRifampinrifapentineRNA, ViralHIV/AIDSpharmacodynamicspharmacokineticsrifapentinetuberculosis

Identifiers

PMID26082504
PMCPMC4583578
OpenAlexW2114609571

What OpenQuestion 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 OpenQuestion graph.