Evidence map›Paper›PMID 12126459›Full record

Trial reportClinical pharmacokinetics2002

Pharmacokinetic interactions between efavirenz and rifampicin in HIV-infected patients with tuberculosis.

Luis F López-Cortés, Rosa Ruiz-Valderas, Pompeyo Viciana, Aristides Alarcón-González, Jesús Gómez-Mateos, Eva León-Jimenez, Maria Sarasanacenta, Yolanda López-Pua, Jerónimo Pachón

Registry-linked trialAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00474435 (The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania), which is not on this map. Cited by 68 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT00474435 phase2unknown statusnot on this mapstarted 2008, after this paper: background citation

The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania

TypeinterventionalSponsorAfrican Poverty Related Infection Oriented Research InitiativeRan2008 to 2009Enrolled30ConditionsTuberculosis, HIV InfectionsArmsEmtricitabine/tenofovir/efavirenz
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 1 synthesis or guideline pooled it, 230 citations in OpenAlex.

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8 more citing papers are in PubMed but not listed here.

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 3 institutions in 1 country.

Luis F López-CortésInfectious Diseases Service, University Hospital Virgen del Rocío, Seville, Spain. lflopez@telefonica.net
Rosa Ruiz-Valderas
Pompeyo Viciana
Aristides Alarcón-González
Jesús Gómez-Mateos
Eva León-Jimenez
Maria Sarasanacenta
Yolanda López-Pua
Jerónimo Pachón
Hospital Universitario Virgen del Rocío · ESHospital Clínic de Barcelona · ESHospital Universitario de Valme · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the pharmacokinetic interactions between efavirenz and rifampicin (rifampin) in patients with HIV infection and tuberculosis.

designNonblind, randomised, pharmacokinetic study. PATIENTS: 24 patients (21 male, 3 female; mean age 37 years) with HIV infection and tuberculosis.

interventionsPatients were randomised to one of the following treatments: group A (n = 16) received antituberculosis drugs without rifampicin, plus highly active antiretroviral therapy (HAART) including efavirenz 600 mg once daily, on days 1 to 7. Patients were then switched to rifampicin in bodyweight-adjusted fixed-dose combination plus HAART including efavirenz 600 mg once daily (group A-1; n = 8) or efavirenz 800 mg once daily (group A-2; n = 8). Group B (n = 8) received rifampicin in bodyweight-adjusted fixed-dose combination on days 1 to 7; on day 8, HAART including efavirenz 800 mg once daily was added. Blood samples were obtained on days 7 and 14.

methodsPlasma concentrations of efavirenz and rifampicin were quantified by using validated high performance liquid chromatography assays, and pharmacokinetic parameter values were determined by noncompartmental methods. The differences between pharmacokinetic parameters on days 7 and 14 were used to assess interactions.

resultsThere was a correlation between the pharmacokinetic parameters of efavirenz and the dose/kg administered. For efavirenz, mean (median) peak concentration, trough concentration and area under the concentration-time curve over the administration interval decreased 24% (24%), 25% (18%) and 22% (10%), respectively, in the presence of rifampicin. Large interpatient variability was observed, suggesting that plasma concentration monitoring of efavirenz may be advisable. Overall, the pharmacokinetics of efavirenz 800 mg plus rifampicin were similar to those of efavirenz 600 mg without rifampicin. The pharmacokinetics of rifampicin did not change substantially in the presence of efavirenz. Differences in patients' bodyweight appeared to cause further differences in exposure to efavirenz. Plasma concentrations of efavirenz in patients weighing <50 kg were similar to those previously described in HIV-infected patients without concomitant tuberculosis. However, plasma concentrations in patients weighing >or=50 kg were almost halved compared with those in patients weighing <50 kg.

conclusionsAlthough the minimal effective efavirenz plasma concentration that assures virological success is not currently known, it may be advisable to increase the dosage of efavirenz to 800 mg once daily when it is coadministered with rifampicin. Rifampicin can be used with efavirenz without dosage modification.

Indexed as

AdultAIDS-Related Opportunistic InfectionsAlkynesAnti-HIV AgentsAntitubercular AgentsArea Under CurveBenzoxazinesCD4 Lymphocyte CountCyclopropanesDrug InteractionsFemaleHalf-LifeHumansMaleMetabolic Clearance RateOxazinesAlkynesAnti-HIV AgentsAntitubercular AgentsBenzoxazinesCyclopropanesefavirenzOxazinesRifampin

Identifiers

PMID12126459
OpenAlexW1998765853

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.