2005
Population Pharmacokinetics of Delavirdine and N-Delavirdine in HIV-Infected Individuals
Smith PF, DiCenzo R, Forrest A, Shelton M, Friedland G, Para M, Pollard R, Fischi M, DiFrancesco R, Morse GD. Population Pharmacokinetics of Delavirdine and N-Delavirdine in HIV-Infected Individuals. Clinical Pharmacokinetics 2005, 44: 99-109. PMID: 15634033, DOI: 10.2165/00003088-200544010-00004.Peer-Reviewed Original ResearchConceptsLarge interpatient variabilityPharmacokinetic parameter estimatesCombination regimensPopulation pharmacokineticsInterpatient variabilityNon-nucleoside reverse transcriptase inhibitorPopulation pharmacokinetic parameter estimatesCells/mm3Double-blind studyHIV-1 infectionMean apparent volumeAge 37 yearsPopulation pharmacokinetic analysisReverse transcriptase inhibitorVolume of distributionFirst-order clearanceTherapeutic drug monitoringTarget drug concentrationsCD4 countMonotherapy studiesOral clearanceDosage regimensPlasma concentrationsTranscriptase inhibitorPharmacokinetic analysis
2002
A Phase II Randomized Study of the Virologic and Immunologic Effect of Zidovudine + Stavudine versus Stavudine Alone and Zidovudine + Lamivudine in Patients with >300 CD4 Cells Who Were Antiretroviral Naive (ACTG 298)
Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A Phase II Randomized Study of the Virologic and Immunologic Effect of Zidovudine + Stavudine versus Stavudine Alone and Zidovudine + Lamivudine in Patients with >300 CD4 Cells Who Were Antiretroviral Naive (ACTG 298). AIDS Research And Human Retroviruses 2002, 18: 699-704. PMID: 12167276, DOI: 10.1089/088922202760072311.Peer-Reviewed Original ResearchConceptsCD4 cell countStandard of careD4TViral loadWeek 12Copies/Cell countMedian baseline viral loadPhase II Randomized StudyD4T armDual nucleoside therapyAntiretroviral-naive patientsBaseline viral loadWeeks of monotherapyViral load reductionTreatment of patientsDevelopment of multidrugAntiretroviral-NaiveAntiviral suppressionNaive patientsCD4 cellsImmunologic effectsHIV infectionRandomized studyNucleoside therapy
1999
Efficacy and Safety of Delavirdine Mesylate With Zidovudine and Didanosine Compared With Two-Drug Combinations of These Agents in Persons With HIV Disease With CD4 Counts of 100 to 500 cells/mm3 (ACTG 261)
Friedland G, Pollard R, Griffith B, Hughes M, Morse G, Bassett R, Freimuth W, Demeter L, Connick E, Nevin T, Hirsch M, Fischl M. Efficacy and Safety of Delavirdine Mesylate With Zidovudine and Didanosine Compared With Two-Drug Combinations of These Agents in Persons With HIV Disease With CD4 Counts of 100 to 500 cells/mm3 (ACTG 261). JAIDS Journal Of Acquired Immune Deficiency Syndromes 1999, 21: 281-292. PMID: 10428106, DOI: 10.1097/00126334-199908010-00005.Peer-Reviewed Original ResearchConceptsCells/mm3CD4 cell countTwo-drug combinationsCell countHIV-1 RNA changesHIV-1 RNA levelsMonths of monotherapyThree-drug regimenTwo-drug armTwo-drug regimensGastrointestinal side effectsThree-drug combinationDelavirdine mesylateNon-nucleoside reverseCD4 countCD4 cellsHIV diseaseKey efficacyMulticenter trialCopies/Antiretroviral activityHIV-1Side effectsDidanosineZidovudine