Trial reportAntimicrobial agents and chemotherapy2001
Pharmacological basis for concentration-controlled therapy with zidovudine, lamivudine, and indinavir.
Trial report in Antimicrobial agents and chemotherapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled 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.
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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Interventions for enhancing medication adherence.The Cochrane database of systematic reviews · 2014Pooled it
- Population pharmacokinetic analysis of lamivudine, stavudine and zidovudine in controlled HIV-infected patients on HAART.European journal of clinical pharmacology · 2007Trial
- Improving data reliability using a non-compliance detection method versus using pharmacokinetic criteria.Journal of pharmacokinetics and pharmacodynamics · 2007Trial
- High variability of indinavir and nelfinavir pharmacokinetics in HIV-infected patients with a sustained virological response on highly active antiretroviral therapy.Clinical pharmacokinetics · 2005Trial
- Population pharmacokinetics of indinavir in patients infected with human immunodeficiency virus.Antimicrobial agents and chemotherapy · 2004Trial
- Population pharmacokinetics and pharmacodynamics of efavirenz, nelfinavir, and indinavir: Adult AIDS Clinical Trial Group Study 398.Antimicrobial agents and chemotherapy · 2003Trial
- Pharmacokinetic-pharmacodynamic analysis of lopinavir-ritonavir in combination with efavirenz and two nucleoside reverse transcriptase inhibitors in extensively pretreated human immunodeficiency virus-infected patients.Antimicrobial agents and chemotherapy · 2003Trial
- Stable concentrations of zidovudine, stavudine, lamivudine, abacavir, and nevirapine in serum and cerebrospinal fluid during 2 years of therapy.Antimicrobial agents and chemotherapy · 2002Trial
- Enhanced Solubility and Bioavailability of Dolutegravir by Solid Dispersion Method: In Vitro and In Vivo Evaluation-a Potential Approach for HIV Therapy.AAPS PharmSciTech · 2021Article
- Combination of Colistin and Azidothymidine Demonstrates Synergistic Activity against Colistin-Resistant, Carbapenem-ResistantMicroorganisms · 2020Article
- Pharmacokinetic Modeling of Lamivudine and Zidovudine Triphosphates Predicts Differential Pharmacokinetics in Seminal Mononuclear Cells and Peripheral Blood Mononuclear Cells.Antimicrobial agents and chemotherapy · 2015Article
- Maternal and fetal zidovudine pharmacokinetics during pregnancy and labour: too high dose infused at labour?British journal of clinical pharmacology · 2014Article
- Validation of a sensitive LC/MS/MS method for the determination of zidovudine and lamivudine in human plasma.Biomedical chromatography : BMC · 2012Article
- Zidovudine and Lamivudine for HIV Infection.Clinical medicine reviews in therapeutics · 2010Article
- Benefit of therapeutic drug monitoring of protease inhibitors in HIV-infected patients depends on PI used in HAART regimen--ANRS 111 trial.Fundamental & clinical pharmacology · 2009Article
- HIV-1 antiretrovirals induce oxidant injury and increase intima-media thickness in an atherogenic mouse model.Toxicology letters · 2009Article
- Long-term exposure to AZT, but not d4T, increases endothelial cell oxidative stress and mitochondrial dysfunction.Cardiovascular toxicology · 2009Article
- Cytokine and sex hormone effects on zidovudine- and lamivudine-triphosphate concentrations in vitro.The Journal of antimicrobial chemotherapy · 2008Article
- Impact of censoring data below an arbitrary quantification limit on structural model misspecification.Journal of pharmacokinetics and pharmacodynamics · 2008Article
- Updated clinical pharmacologic considerations for HIV-1 protease inhibitors.Current HIV/AIDS reports · 2004Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
Conventional antiretroviral therapy involves administration of standard fixed doses to adults and adolescents. This approach ignores interindividual variability in pharmacokinetics and results in substantial differences in systemic concentrations among patients. Thus, variability in systemic concentrations contributes to variability in response to therapy. This study was designed to evaluate the feasibility and safety of a regimen of zidovudine, lamivudine, and indinavir designed to achieve select target concentrations versus standard dose therapy. Twenty-four antiretroviral-naïve subjects completed the 24-week study; 13 received standard therapy, and 11 received concentration-controlled therapy. There were no differences in baseline characteristics. Oral clearance for all three drugs was not different between weeks 2 and 28; average ratios of week 2 oral clearance to week 28 oral clearance were 0.95, 1.09, and 1.06 for zidovudine, lamivudine, and indinavir, respectively, with 95% confidence intervals including 1. The selected target concentrations were average steady-state concentrations of 0.19 mg/liter for zidovudine and 0.44 mg/liter for lamivudine and a trough concentration of 0.15 mg/liter for indinavir; mean concentrations achieved at week 28 in the concentration-controlled arm were 0.20, 0.54, and 0.19 mg/liter, respectively. Concentration-controlled therapy significantly reduced interpatient variability in zidovudine concentrations and significantly increased indinavir concentrations. There was no difference in adverse drug effects or adherence. This investigation has provided a pharmacologic basis for concentration-controlled therapy by demonstrating that it is feasible and has a safety profile no different from that of standard therapy. Additional studies to evaluate the virologic effect of the concentration-controlled approach to antiretroviral therapy are warranted.
Indexed as
Identifiers
What OpenQuestion holds
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.