Trial reportBritish journal of clinical pharmacology2008
A novel probe drug interaction study to investigate the effect of selected antiretroviral combinations on the pharmacokinetics of a single oral dose of maraviroc in HIV-positive subjects.
Trial report in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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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.
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.
Who cites it
12 citing papers in PubMed, 24 citations in OpenAlex.
- Impact of Efavirenz-, Ritonavir-Boosted Lopinavir-, and Nevirapine-Based Antiretroviral Regimens on the Pharmacokinetics of Lumefantrine and Safety of Artemether-Lumefantrine in Plasmodium falciparum-Negative HIV-Infected Malawian Adults Stabilized on Antiretroviral Therapy.Antimicrobial agents and chemotherapy · 2018Trial
- Pharmacokinetics of Piperaquine and Safety Profile of Dihydroartemisinin-Piperaquine Coadministered with Antiretroviral Therapy in Malaria-Uninfected HIV-Positive Malawian Adults.Antimicrobial agents and chemotherapy · 2018Trial
- Concomitant efavirenz reduces pharmacokinetic exposure to the antimalarial drug artemether-lumefantrine in healthy volunteers.Journal of acquired immune deficiency syndromes (1999) · 2012Trial
- Interaction between artemether-lumefantrine and nevirapine-based antiretroviral therapy in HIV-1-infected patients.Antimicrobial agents and chemotherapy · 2011Trial
- Dexamethasone is a dose-dependent perpetrator of drug-drug interactions: implications for use in people living with HIV.The Journal of antimicrobial chemotherapy · 2022Article
- Concomitant nevirapine impacts pharmacokinetic exposure to the antimalarial artemether-lumefantrine in African children.PloS one · 2017Article
- Maraviroc: a review of its use in HIV infection and beyond.Drug design, development and therapy · 2015Review
- CYP3A5 genotype impacts maraviroc concentrations in healthy volunteers.Drug metabolism and disposition: the biological fate of chemicals · 2014Article
- Antiretroviral drug interactions: overview of interactions involving new and investigational agents and the role of therapeutic drug monitoring for management.Pharmaceutics · 2011Article
- Cobicistat (GS-9350): A Potent and Selective Inhibitor of Human CYP3A as a Novel Pharmacoenhancer.ACS medicinal chemistry letters · 2010Article
- Drug interactions with new and investigational antiretrovirals.Clinical pharmacokinetics · 2009Review
- Clinical pharmacokinetics of darunavir.Clinical pharmacokinetics · 2007Review
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsMaraviroc (UK-427 857), an antagonist of the CCR5 receptor with potent anti-HIV activity, was recently approved for use in treatment-experienced patients infected with CCR5-tropic HIV-1. The aim of this study was to evaluate the effect of selected commonly used antiretroviral therapy (ART) combinations on the pharmacokinetics of a single oral dose of maraviroc 300 mg in HIV-positive subjects compared with historical controls.
methodsIn this study, four cohorts of HIV-positive patients (n = 8 each) receiving one of the following combination therapies were recruited: cohort 1--efavirenz + Combivir (lamivudine/zidovudine); cohort 2--efavirenz + didanosine + tenofovir; cohort 3--nevirapine + lamivudine + tenofovir; cohort 4--Kaletra (lopinavir/ritonavir) + stavudine + lamivudine. Subjects continued on their prescribed ART and also received a single oral dose of maraviroc 300 mg. Serial blood samples and urine for determination of maraviroc pharmacokinetics were collected over 12 h postdose. Plasma pharmacokinetic parameters from this study were compared with historical data generated in HIV-positive subjects receiving maraviroc monotherapy in a Phase IIa study.
resultsA total of 29 subjects were recruited (eight each in cohorts 1-3, and five in cohort 4). The geometric mean ratios for AUC(12) and C(max) for each treatment group compared with maraviroc monotherapy were: 47% and 67% (cohort 1); 48% and 76% (cohort 2); 101% and 154% (cohort 3); and 265% and 180% (cohort 4), respectively. T(max) was similar in all treatment groups. Mean values for renal clearance ranged from 8.2 l h(-1) (cohort 1) to 13.2 l h(-1) (cohort 4). There were no renal clearance data collected in the comparator study.
conclusionsThe results of this study support those previously seen in healthy volunteer studies that showed that efavirenz reduces maraviroc exposure, whereas lopinavir/ritonavir increases maraviroc exposure. These data also suggest that nevirapine does not lead to a clinically significant effect on maraviroc pharmacokinetics.
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