Evidence map›Paper›PMID 38739755›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries.

N Sarita Shah, Cissy Kityo, Michael D Hughes, Caitlyn McCarthy, Carole L Wallis, Mina C Hosseinipour, Deborah Langat, Mulinda Nyirenda, Mohammed Rassool, Rodney Dawson and 11 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

21 authors.

N Sarita ShahEmory Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.ORCID 0000-0001-6069-0857
Cissy KityoJoint Clinical Research Centre, Kampala, Uganda.
Michael D HughesCenter for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Caitlyn McCarthyCenter for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Carole L WallisLancet Laboratories and BARC-SA, Johannesburg, South Africa.
Mina C HosseinipourUniversity of North Carolina at Chapel Hill, School of Medicine, Department of Medicine, Chapel Hill, North Carolina, USA.
Deborah LangatDepartment of Research, Walter Reed Project-Kericho, Kenya.
Mulinda NyirendaCollege of Medicine, Johns Hopkins Research Project, Blantyre, Malawi.
Mohammed RassoolClinical HIV Research Unit, Wits Health Consortium, Health Science Research Office, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Rodney DawsonDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Yvetot JosephGHESKIO Institute of Infectious Diseases and Reproductive Health, Port-au-Prince, Haiti.
Fatma SomeDepartment of Medicine, Moi University Clinical Research Centre, Eldoret, Kenya.
Rosie MngqibisaDurban Clinical Research Site, Enhancing Care Foundation, Wentworth Hospital, Durban, South Africa.
Pamela Grace MukwekwerereMilton Park Clinical Research Site, University of Zimbabwe, Harare, Zimbabwe.
Elizabeth WoolleySocial & Scientific Systems, Inc, A DLH Holdings Company, Bethesda, Maryland, USA.
Catherine GodfreyBureau of Global Health Security and Diplomacy/PEPFAR, US Department of State, Washington, DC, USA.
Yukari C ManabeDepartments of Medicine, Pharmacology, and International Health, Johns Hopkins University School of Medicine and Bloomberg School of Public Health, Baltimore, Maryland, USA.
John W MellorsUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Charles FlexnerDepartments of Medicine, Pharmacology, and International Health, Johns Hopkins University School of Medicine and Bloomberg School of Public Health, Baltimore, Maryland, USA.
Gary MaartensDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
ACTG A5381/Hakim Study Team

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
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
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
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
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 Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
University of Cape Town Clinical Trials Unit (UCTCTU)UM1AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI Linda-Gail Bekker · 2012 to 2026
$36.3M
ACTG UM1AI69518Emory Georgia TB Research Advancement Center K24AI165099National Institute of Allergy and Infectious DiseasesNIAID NIH HHS K24 AI165099NIAID NIH HHS P30 AI168386NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI06866NIAID NIH HHS UM1 AI069421NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI069519NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI108568NIH HHS UM1 AI068634
6 · The paper itself

Abstract

backgroundTenofovir-lamivudine-dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen. An additional 50-mg dose of dolutegravir (TLD+50) is required with rifampin-containing tuberculosis (TB) co-treatment. There are limited data on the effectiveness of TLD+50 in individuals with TB/human immunodeficiency virus (HIV).

methodsWe performed a prospective, observational cohort study at 12 sites in Haiti, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Participants starting TLD and rifampin-containing TB treatment were eligible. The primary outcome was HIV-1 RNA ≤1000 copies/mL at end of TB treatment.

resultsWe enrolled 91 participants with TB/HIV: 75 (82%) ART-naive participants starting TLD after a median 15 days on TB treatment, 10 (11%) ART-naive participants starting TLD and TB treatment, 5 (5%) starting TB treatment after a median 3.3 years on TLD, and 1 (1%) starting TB treatment and TLD after changing from efavirenz-lamivudine-tenofovir. Median age was 37 years, 35% were female, the median CD4 count was 120 cells/mm3 (interquartile range, 50-295), and 87% had HIV-1 RNA >1000 copies/mL. Among 89 surviving participants, 80 were followed to TB treatment completion, including 7 who had no HIV-1 RNA result due to missed visits. The primary virologic outcome was assessed in 73 participants, 69 of whom (95%; 95% confidence interval, 89%-100%) had HIV-1 RNA ≤1000 copies/mL. No dolutegravir resistance mutations were detected among 4 participants with HIV-1 RNA >1000 copies/mL.

conclusionsIn programmatic settings, concurrent rifampin-containing TB treatment and TLD+50 was feasible, well tolerated, and achieved high viral suppression rates in a cohort of predominantly ART-naive people with TB/HIV.

Indexed as

Anti-HIV AgentsAntitubercular AgentsHeterocyclic Compounds, 3-RingHIV InfectionsRifampinTuberculosisAdultCohort StudiesCoinfectionDolutegravirDrug Therapy, CombinationFemaleHIV-1HumansLamivudineMaleAnti-HIV AgentsAntitubercular AgentsDolutegravirHeterocyclic Compounds, 3-RingLamivudineOxazinesPiperazinesPyridonesRifampinRNA, Viralantiretroviral treatmentdrug–drug interactionsHIVtuberculosis

Identifiers

PMID38739755
PMCPMC11797024

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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.