Trial reportAntimicrobial agents and chemotherapy2008
Minimal effects of ritonavir and efavirenz on the pharmacokinetics of raltegravir.
Trial report in Antimicrobial agents and chemotherapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00977756 (IMPAACT P1058A), which is not on this map. Cited by 24 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.
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults
Who cites it
24 citing papers in PubMed.
- Raltegravir pharmacokinetics during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2014Trial
- Effect of tipranavir-ritonavir on pharmacokinetics of raltegravir.Antimicrobial agents and chemotherapy · 2009Trial
- Drug-Drug Interactions Between HIV Antivirals and Concomitant Drugs in HIV Patients: What We Know and What We Need to Know.Pharmaceutics · 2024Review
- Combined Oral Contraceptives As Victims of Drug Interactions.Drug metabolism and disposition: the biological fate of chemicals · 2023Review
- Influence of UGT1A1 and SLC22A6 polymorphisms on the population pharmacokinetics and pharmacodynamics of raltegravir in HIV-infected adults: a NEAT001/ANRS143 sub-study.The pharmacogenomics journal · 2023Article
- Pharmacokinetic drug interactions of integrase strand transfer inhibitors.Current research in pharmacology and drug discovery · 2021Review
- Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling.Clinical pharmacokinetics · 2020Article
- Drug-Drug Interaction Profile of the Fixed-Dose Combination Tablet Regimen Ledipasvir/Sofosbuvir.Clinical pharmacokinetics · 2018Review
- P-glycoprotein (ABCB1) activity decreases raltegravir disposition in primary CD4+P-gphigh cells and correlates with HIV-1 viral load.The Journal of antimicrobial chemotherapy · 2016Article
- Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir.Clinical pharmacokinetics · 2015Review
- Long-term efficacy and safety of raltegravir in the management of HIV infection.Infection and drug resistance · 2014Review
- Raltegravir does not revert efflux activity of MDR1-P-glycoprotein in human MDR cells.BMC pharmacology & toxicology · 2013Article
- Raltegravir for HIV-1 infected children and adolescents: efficacy, safety, and pharmacokinetics.Adolescent health, medicine and therapeutics · 2013Review
- Population pharmacokinetic analysis and pharmacogenetics of raltegravir in HIV-positive and healthy individuals.Antimicrobial agents and chemotherapy · 2012Article
- Raltegravir is a substrate for SLC22A6: a putative mechanism for the interaction between raltegravir and tenofovir.Antimicrobial agents and chemotherapy · 2011Article
- Role of raltegravir in the management of HIV-1 infection.HIV/AIDS (Auckland, N.Z.) · 2011Article
- Prevention of HIV protease inhibitor-induced dysregulation of hepatic lipid metabolism by raltegravir via endoplasmic reticulum stress signaling pathways.The Journal of pharmacology and experimental therapeutics · 2010Article
- Raltegravir: The evidence of its therapeutic value in HIV-1 infection.Core evidence · 2010Article
- Intracellular and plasma steady-state pharmacokinetics of raltegravir, darunavir, etravirine and ritonavir in heavily pre-treated HIV-infected patients.British journal of clinical pharmacology · 2010Article
- Drug-drug interactions with raltegravir.European journal of medical research · 2009Review
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Raltegravir is a novel human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor with potent in vitro activity against HIV-1 (95% inhibitory concentration = 31 nM in 50% human serum). The possible effects of ritonavir and efavirenz on raltegravir pharmacokinetics were separately examined. Two clinical studies of healthy subjects were conducted: for ritonavir plus raltegravir, period 1, 400 mg raltegravir; period 2, 100 mg ritonavir every 12 h for 16 days with 400 mg raltegravir on day 14; for efavirenz plus raltegravir, period 1, 400 mg raltegravir; period 2, 600 mg efavirenz once daily for 14 days with 400 mg raltegravir on day 12. In the presence of ritonavir, raltegravir pharmacokinetics were weakly affected: the plasma concentration at 12 h (C(12 h)) geometric mean ratio (GMR) (90% confidence interval [CI]) was 0.99 (0.70, 1.40), area under the concentration-time curve from zero to infinity (AUC(0-infinity)) was 0.84 (0.70, 1.01), and maximum concentration of drug in serum (C(max)) was 0.76 (0.55, 1.04). In the presence of efavirenz, raltegravir pharmacokinetics were moderately to weakly reduced: C(12 h) GMR (90% CI) was 0.79 (0.49, 1.28); AUC(0-infinity) was 0.64 (0.52, 0.80); and C(max) was 0.64 (0.41, 0.98). There were no substantial differences in the time to maximum concentration of drug in plasma or the half-life. Plasma concentrations of raltegravir were not substantially affected by ritonavir. Though plasma concentrations of raltegravir were moderately to weakly reduced by efavirenz, the degree of this reduction was not clinically meaningful. No dose adjustment is required for raltegravir with coadministration with ritonavir or efavirenz.
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