Trial reportAAPS pharmSci2000
Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection.
Trial report in AAPS pharmSci, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Stavudine, lamivudine and nevirapine combination therapy for treatment of HIV infection and AIDS in adults.The Cochrane database of systematic reviews · 2006Pooled it
- Pharmacokinetics of Ruxolitinib in HIV Suppressed Individuals on Antiretroviral Agent Therapy from the ACTG A5336 Study.Journal of clinical pharmacology · 2021Trial
- Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women.AIDS (London, England) · 2012Trial
- Population pharmacokinetic-pharmacogenetic study of nevirapine in HIV-infected Cambodian patients.Antimicrobial agents and chemotherapy · 2010Trial
- Pharmacokinetics of dolutegravir, tenofovir and lamivudine during venous-venous extracorporeal membrane oxygenation (VV-ECMO): A case report.British journal of clinical pharmacology · 2026Article
- Renal Drug Transporters and Drug Interactions.Clinical pharmacokinetics · 2017Review
- Pharmacokinetics of phase I nevirapine metabolites following a single dose and at steady state.Antimicrobial agents and chemotherapy · 2013Article
- Integration of data from multiple sources for simultaneous modelling analysis: experience from nevirapine population pharmacokinetics.British journal of clinical pharmacology · 2012Article
- Association of Nevirapine Levels with Rash or Hepatotoxicity Among HIV-Infected Thai Women.The open AIDS journal · 2012Article
- Pharmacokinetics of lamivudine & stavudine in generic fixed-dose combinations in HIV-1 infected adults in India.The Indian journal of medical research · 2009Article
- Population pharmacokinetics of nevirapine in combination with rifampicin-based short course chemotherapy in HIV- and tuberculosis-infected South African patients.European journal of clinical pharmacology · 2009Article
- Genetic, ethnic, and gender differences in the pharmacokinetics of antiretroviral agents.Current HIV/AIDS reports · 2006Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The purpose of this parallel treatment group, double-blind, multicenter study was to characterize the pharmacokinetics of nevirapine and lamivudine when coadministered to patients with the HIV-1 infection. This pharmacokinetic interaction study was nested within a larger Phase III clinical trial conducted to characterize the safety and efficacy of coadministered nevirapine and lamivudine. One hundred HIV-1 infected patients with CD4+ lymphocyte counts < 200 cells/mm3and who were on a background of nucleoside (zidovudine [ZDV], didanosine [ddI], zalcitabine [ddC], stavudine [d4T]) therapy were randomly assigned to be treated with either nucleoside + lamivudine + nevirapine or nucleoside + lamivudine + placebo. Each patient underwent blood sampling at defined times for the purpose of determining the concentration of nevirapine in plasma and lamivudine in serum under steady-state conditions. Each patient was also monitored closely for concomitant administration of other drugs, including ZDV, ddI, ddC, d4T and cotrimoxazole. The pharmacokinetics of nevirapine and lamivudine were characterized using nonlinear mixed-effects modeling. There were no reported serious adverse events during the 40-day pharmacokinetic study. The results of the modeling analysis revealed that nevirapine had no effect on the pharmacokinetics of lamivudine. Estimates of the apparent clearance for nevirapine (CL/F = 3.3 L/hour; 95% confidence interval [CI] 2.9 to 3.7 L/hour) and lamivudine (CL/F 27.6 L/hour; 95% CI 22 to 33.2 L/hour) were consistent with the values reported in earlier trials. However, the results also showed that concomitant administration of lamivudine with cotrimoxazole resulted in a 31% reduction in the apparent clearance of lamivudine, resulting in a 43% increase in the average steady-state lamivudine serum concentrations. These results indicate that chronic concurrent administration of cotrimoxazole with lamivudine may significantly affect the steady-state pharmacokinetics of lamivudine.
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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.