Evidence map›Paper›PMID 24465443›Full record

Trial reportPloS one2014

Randomised pharmacokinetic trial of rifabutin with lopinavir/ritonavir-antiretroviral therapy in patients with HIV-associated tuberculosis in Vietnam.

Nguyen Thi Ngoc Lan, Nguyen Thi Nguyet Thu, Aurélie Barrail-Tran, Nguyen Hong Duc, Nguyen Ngoc Lan, Didier Laureillard, Truong Thi Xuan Lien, Laurence Borand, Catherine Quillet, Catherine Connolly and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00651066 (Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in the Treatment of Tuberculosis Patient With HIV Infection in Vietnam), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
4.1field-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.

NCT00651066 phase2completednot on this map

Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in the Treatment of Tuberculosis Patient With HIV Infection in Vietnam : A Phase II Trial

TypeinterventionalSponsorFrench National Agency for Research on AIDS and Viral HepatitisRan2010 to 2012Enrolled47ConditionsHIV Infections, TuberculosisArmsrifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1, rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Next-generation rifamycins for the treatment of mycobacterial infections.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
  7. Article
  8. Article
  9. Hepatic Disorders and COVID-19: From Pathophysiology to Treatment Strategy.Canadian journal of gastroenterology & hepatology · 2022
    Review
  10. Mechanism of SARS-CoV-2 Invasion into the Liver and Hepatic Injury in Patients with COVID-19.Mediterranean journal of hematology and infectious diseases · 2022
    Review
  11. Liver injury in COVID-19: Known and unknown.World journal of clinical cases · 2021
    Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. [Research progress on the clinical features and mechanisms of COVID-19 combined with liver injury].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2020
    Article
  18. Article
  19. Management of Virologic Failure and HIV Drug Resistance.Infectious disease clinics of North America · 2019
    Review
  20. 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

16 authors at 8 institutions in 7 countries.

Nguyen Thi Ngoc LanPham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
Nguyen Thi Nguyet ThuPasteur Institute, Ho Chi Minh City, Vietnam.
Aurélie Barrail-TranClinical Pharmacy Department, Bicêtre Hospital, Assistance-Publique Hôpitaux de Paris, Kremlin-Bicêtre, France ; Clinical Pharmacy and Pharmacokinetics Department (EA4123), University Paris Sud, Chatenay Malabry, France.
Nguyen Hong DucPham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
Nguyen Ngoc LanPham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
Didier LaureillardANRS, Ho Chi Minh City, Vietnam.
Truong Thi Xuan LienPasteur Institute, Ho Chi Minh City, Vietnam.
Laurence BorandEpidemiology and Public Health Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia.
Catherine QuilletANRS, Ho Chi Minh City, Vietnam.
Catherine ConnollyBiostatistics Unit, Medical Research Council, Durban, South Africa.
Dominique LagardeThe International Union Against Tuberculosis and Lung Diseases, Paris, France.
Alexander PymTB Research Unit, Medical Research Council, Durban, South Africa ; KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH), South Africa.
Christian LienhardtWorld Health Organization Stop Tuberculosis Program, Geneva, Switzerland.
Nguyen Huy DungPham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
Anne-Marie TaburetClinical Pharmacy Department, Bicêtre Hospital, Assistance-Publique Hôpitaux de Paris, Kremlin-Bicêtre, France.
Anthony D HarriesThe International Union Against Tuberculosis and Lung Diseases, Paris, France ; London School of Hygiene and Tropical Medicine, London, United Kingdom.
Assistance Publique – Hôpitaux de Paris · FRInstitut Pasteur in Ho Chi Minh City · VNAfrica Health Research Institute · ZAInstitut Pasteur du Cambodge · KHInternational Union Against Tuberculosis and Lung Disease · FRSouth African Medical Research Council · ZAUniversity of London · GBWorld Health Organization - Pakistan · PK

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundRifampicin and protease inhibitors are difficult to use concomitantly in patients with HIV-associated tuberculosis because of drug-drug interactions. Rifabutin has been proposed as an alternative rifamycin, but there is concern that the current recommended dose is suboptimal. The principal aim of this study was to compare bioavailability of two doses of rifabutin (150 mg three times per week and 150 mg daily) in patients with HIV-associated tuberculosis who initiated lopinavir/ritonavir-based antiretroviral therapy in Vietnam. Concentrations of lopinavir/ritonavir were also measured.

methodsThis was a randomized, open-label, multi-dose, two-arm, cross-over trial, conducted in Vietnamese adults with HIV-associated tuberculosis in Ho Chi Minh City (Clinical trial registry number NCT00651066). Rifabutin pharmacokinetics were evaluated before and after the introduction of lopinavir/ritonavir -based antiretroviral therapy using patient randomization lists. Serial rifabutin and 25-O-desacetyl rifabutin concentrations were measured during a dose interval after 2 weeks of rifabutin 300 mg daily, after 3 weeks of rifabutin 150 mg daily with lopinavir/ritonavir and after 3 weeks of rifabutin 150 mg three times per week with lopinavir/ritonavir.

resultsSixteen and seventeen patients were respectively randomized to the two arms, and pharmacokinetic analysis carried out in 12 and 13 respectively. Rifabutin 150 mg daily with lopinavir/ritonavir was associated with a 32% mean increase in rifabutin average steady state concentration compared with rifabutin 300 mg alone. In contrast, the rifabutin average steady state concentration decreased by 44% when rifabutin was given at 150 mg three times per week with lopinavir/ritonavir. With both dosing regimens, 2 - 5 fold increases of the 25-O-desacetyl- rifabutin metabolite were observed when rifabutin was given with lopinavir/ritonavir compared with rifabutin alone. The different doses of rifabutin had no significant effect on lopinavir/ritonavir plasma concentrations.

conclusionsBased on these findings, rifabutin 150 mg daily may be preferred when co-administered with lopinavir/ritonavir in patients with HIV-associated tuberculosis.

trial registrationClinicalTrials.gov NCT00651066.

Indexed as

AdultAntibiotics, AntitubercularArea Under CurveAsian PeopleBiological AvailabilityChemical and Drug Induced Liver InjuryCross-Over StudiesDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHIV InfectionsHIV Protease InhibitorsHumansLopinavirMaleRifabutinAntibiotics, AntitubercularHIV Protease InhibitorsLopinavirRifabutinRitonavir

Identifiers

PMID24465443
PMCPMC3898920
OpenAlexW2060396702

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.