ArticleAntimicrobial agents and chemotherapy2004
Quality assurance program for clinical measurement of antiretrovirals: AIDS clinical trials group proficiency testing program for pediatric and adult pharmacology laboratories.
Article in Antimicrobial agents and chemotherapy, 2004. 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 28 papers.
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.
The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania
Who cites it
28 citing papers in PubMed, 61 citations in OpenAlex.
- Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015Trial
- Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2013Trial
- Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum.Journal of acquired immune deficiency syndromes (1999) · 2012Trial
- Pharmacokinetics of lopinavir/ritonavir crushed versus whole tablets in children.Journal of acquired immune deficiency syndromes (1999) · 2011Trial
- Therapeutic drug monitoring of protease inhibitors and efavirenz in HIV-infected individuals with active substance-related disorders.Therapeutic drug monitoring · 2011Trial
- Atazanavir pharmacokinetics with and without tenofovir during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2011Trial
- Quality assessment for therapeutic drug monitoring in AIDS Clinical Trials Group (ACTG 5146): a multicenter clinical trial.Therapeutic drug monitoring · 2010Trial
- Influence of CYP2B6 polymorphisms on the persistence of plasma nevirapine concentrations following a single intra-partum dose for the prevention of mother to child transmission in HIV-infected Thai women.The Journal of antimicrobial chemotherapy · 2009Trial
- Lopinavir exposure with an increased dose during pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2008Trial
- Plasma drug concentrations and virologic evaluations after stopping treatment with nonnucleoside reverse-transcriptase inhibitors in HIV type 1-infected children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2008Trial
- Pharmacokinetic interaction between efavirenz and dual protease inhibitors in healthy volunteers.Biopharmaceutics & drug disposition · 2008Trial
- Amprenavir and efavirenz pharmacokinetics before and after the addition of nelfinavir, indinavir, ritonavir, or saquinavir in seronegative individuals.Antimicrobial agents and chemotherapy · 2005Trial
- Clinical Pharmacology Quality Assurance Program for Global HIV and Co-Infection Drug Development.Clinical pharmacology and therapeutics · 2026Review
- HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies.Clinical pharmacology and therapeutics · 2025Review
- Development and validation of a high performance liquid chromatography method to determine nevirapine in plasma in a resource-limited setting.African journal of laboratory medicine · 2019Article
- Efavirenz pharmacokinetics during pregnancy and infant washout.Antiviral therapy · 2019Article
- Plasma and Intracellular Pharmacokinetics of Tenofovir Disoproxil Fumarate 300 mg Every 48 Hours vs 150 mg Once Daily in HIV-Infected Adults With Moderate Renal Function Impairment.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015Article
- Adding value to antiretroviral proficiency testing.Bioanalysis · 2014Article
- Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories.Therapeutic drug monitoring · 2013Article
- Reduced indinavir exposure during pregnancy.British journal of clinical pharmacology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
Clinical trials designed to compare antiretroviral regimens, investigate therapeutic drug monitoring, or measure pharmacometrics often include protease inhibitors (PIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), and nucleoside reverse transcriptase inhibitors, requiring the measurement of these antiretrovirals in plasma. Within the adult and pediatric AIDS Clinical Trials Group (ACTG), a network of Pharmacology Support Laboratories (PSLs) is a component of the group laboratory infrastructure and conducts these types of pharmacologic assays. The adult ACTG has developed a comprehensive quality assurance program for the conduct of clinical pharmacology protocols, one component of which is the antiretroviral proficiency testing (PT) program that has been implemented between the adult and pediatric pharmacology laboratories of the ACTG. PT testing samples were prepared and distributed in July 2001, February 2002, and July 2002. High, medium, and low concentrations of PIs (indinavir, saquinavir, amprenavir, lopinavir, ritonavir, and nelfinavir) and NNRTIs (nevirapine and efavirenz) were added to drug-free EDTA plasma and distributed, on dry ice, to eight ACTG PSLs. One testing laboratory used liquid chromatography-tandem mass spectrometry, and seven used high-performance liquid chromatography-UV analysis. A result was considered acceptable if it was within 20% deviation of the assigned concentration. For all concentrations of PIs evaluated, 96% of samples tested (430 of 448 measurements) met the acceptance criteria. For both NNRTIs, 100% of samples tested (140 of 140 measurements) met the acceptance criteria. In conclusion, the PT program results presented demonstrate excellent interlaboratory agreement for all antiretrovirals tested and provide support for the merger of plasma concentration data among laboratories for large clinical trials.
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.