2024
Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans
Yu Q, George S, Kyriakides T, Rhon D, Morasco B, Dziura J, Fritz J, Geda M, Peduzzi P, Long C. Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans. Pain Medicine 2024, 25: s49-s53. PMID: 39514871, PMCID: PMC11548855, DOI: 10.1093/pm/pnae073.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPain Management CollaboratoryStatistical analysis planTrial protocolAnalysis planEvaluate nonpharmacological interventionsNonpharmacological interventionsTrial launchStudy designSecondary outcomesTrials RegistryPrimary outcomeStudy armsPrincipal investigatorInstitutional review boardClinical trialsTrial initiationCOVID-19-related issuesBest practicesPainSample sizeReview boardSafety monitoring boardOutcomesTrialsMonitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions
Burns A, Young-McCaughan S, Davis A, Vining R, Ali J, Fritz J, Morasco B, Rhon D, Roogow R, Kyriakides T, Kerns R. Monitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions. Pain Medicine 2024, 25: s64-s67. PMID: 39514880, PMCID: PMC11548853, DOI: 10.1093/pm/pnae081.Peer-Reviewed Original ResearchA randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection
Drekonja D, Shaukat A, Huang Y, Zhang J, Reinink A, Nugent S, Dominitz J, Davis-Karim A, Gerding D, Kyriakides T. A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection. Clinical Infectious Diseases 2024, ciae467. PMID: 39271107, DOI: 10.1093/cid/ciae467.Peer-Reviewed Original ResearchCDI recurrenceClostridioides difficile infectionFecal microbiota transplantationRecurrent Clostridioides difficile infectionAdverse eventsPreventing recurrent Clostridioides difficile infectionOral fecal microbiota transplantationMicrobiota transplantationCause of healthcare-associated infectionsSafety of fecal microbiota transplantationDouble-blind clinical trialTrials of efficacyHealthcare-associated infectionsStatistically significant differenceRandomized controlled trialsClinical recurrenceUnformed stoolsPlacebo armPlacebo capsulesPrimary endpointDifficile infectionRecurrent diarrheaAntibiotic treatmentVeterans Health Administration systemClinical trials
2023
Scientific evidence supporting the newly developed one-health labeling tool “Med-Index”: an umbrella systematic review on health benefits of mediterranean diet principles and adherence in a planeterranean perspective
Zupo R, Castellana F, Piscitelli P, Crupi P, Desantis A, Greco E, Severino F, Pulimeno M, Guazzini A, Kyriakides T, Vasiliou V, Trichopoulou A, Soldati L, La Vecchia C, De Gaetano G, Donati M, Colao A, Miani A, Corbo F, Clodoveo M. Scientific evidence supporting the newly developed one-health labeling tool “Med-Index”: an umbrella systematic review on health benefits of mediterranean diet principles and adherence in a planeterranean perspective. Journal Of Translational Medicine 2023, 21: 755. PMID: 37885010, PMCID: PMC10601192, DOI: 10.1186/s12967-023-04618-1.Peer-Reviewed Original ResearchConceptsMediterranean diet principlesSystematic reviewAge-related chronic diseasesUmbrella systematic reviewHealth benefitsScientific evidenceRenal healthResultsA totalClinical trialsLiver healthChronic diseasesEligible reviewsObservational studyMedDiet patternEligible publicationsPremature mortalityHealth outcomesPubMed databaseIndependent investigatorsRCT designNeurological disordersObservational designSignificant associationMedDietHealthy nutritionBaseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial
Robertson D, Dominitz J, Beed A, Boardman K, Del Curto B, Guarino P, Imperiale T, LaCasse A, Larson M, Gupta S, Lieberman D, Planeta B, Shaukat A, Sultan S, Menees S, Saini S, Schoenfeld P, Goebel S, von Rosenvinge E, Baffy G, Halasz I, Pedrosa M, Kahng L, Cassim R, Greer K, Kinnard M, Bhatt D, Dunbar K, Harford W, Mengshol J, Olson J, Patel S, Antaki F, Fisher D, Sullivan B, Lenza C, Prajapati D, Wong H, Beyth R, Lieb J, Manlolo J, Ona F, Cole R, Khalaf N, Kahi C, Kohli D, Rai T, Sharma P, Anastasiou J, Hagedorn C, Fernando R, Jackson C, Jamal M, Lee R, Merchant F, May F, Pisegna J, Omer E, Parajuli D, Said A, Nguyen T, Tombazzi C, Feldman P, Jacob L, Koppelman R, Lehenbauer K, Desai D, Madhoun M, Tierney W, Ho M, Hockman H, Lopez C, Carter Paulson E, Tobi M, Pinillos H, Young M, Ho N, Mascarenhas R, Promrat K, Mutha P, Pandak W, Shah T, Schubert M, Pancotto F, Gawron A, Underwood A, Ho S, Magno-Pagatzaurtundua P, Toro D, Beymer C, Kaz A, Elwing J, Gill J, Goldsmith S, Yao M, Protiva P, Pohl H, Kyriakides T, Kleiner E, Sullivan K, O'Leary J, Chiu W, Huang H, Russo J, Johnson G, Antonelli P, Burns A, Peduzzi P, Ciarleglio M, O'Connor T, Wallace R, Williams A, Tommessilli L, Taylor S, Pitts S, Mancini L, O'Brien P, O'Neil S, Perry M, McBride V, Carr W, Joncas C, O'Donnell E, Sather M, Warren S, Conner T, Honstein E, Sutton T, Putnam T, Branham K, Argyres D, Peterson D, Kennedy A, Carrick T, Apodaca C, Eden G, Martinez T, Tripp C, Nicholson M, Schwartz A, Felix M, Ward A, Marquez L, Lovato K, Cochran N, Tapia S, VanRaden M, Badgett C, Taylor Z, Pontzer J, Dorman B, Chavez M, Georg S, Templton T, Calais L, Haakensen C, Curtis B, Prehoda M, Colling C, Older D, Apodaca G, Sova J, Klee M, Wolfram-Aduan A, Ulatowski M, Hamilton B, Bopp (Formerly England) K, Ford G, Lace N, McDonnell W, Piehl G, Patel-Ejarque N, Berry M, Strubeck E, Chesnut L, Burridge L, Bean J, Kowal L, Voorhees (Formerly Rose) A, Ridley A, Croteau H, Bessett K, Fletcher C, Barbaresso M, Drummond A, Belanger K, McRobert E, Myers A, Trumble E, Rose P, Biswas A, Enache E, Shankin M, Strunk D, Simpson A, Harrison M, Prasad M, Robinson P, Flores A, Jananeh S, Tanukonda S, Ahmadi-Izadi G, Madihi S, Raufman J, Grady D, Britton A, Goldstein C, Thomas M, Lee V, Belizaire M, Costa C, Davis S, Decker M, Marrama A, Gilroy-Fanaras D, Gass J, Reece S, Tobin D, Carroll R, Ferreira M, Irvin D, Morken V, Covelli M, Medina T, Schiebel F, Shreves A, Shriver D, Frederick Y, Postle (formerly Matheny) C, Shaw J, Pastor D, Armstrong A, Kumaran V, Pinto A, Marshall V, McLarty S, Carlton J, Murphy K, McLemore K, Mortensen E, LePage J, Willis C, Berman K, Dunn T, Espinoza J, Schleski E, Shrader S, Gropp K, Kanaan Z, Miller L, Anees M, Judd S, Berchou V, Balogh D, Jones E, Covert K, Davis Y, Marbury C, Rambus M, Olgren E, Gellad Z, Sullivan B, Day T, Teehan S, Peters L, Hernandez-Chavez R, Murphy E, Cherry J, Graham E, Johnson J, Wooten W, Trujillo J, Harris M, Alizadeh M, Lo M, Sultan S, Brown L, Koster L, LeLaurin J, Irwin A, Kay N, Mckillip S, Lowe M, Yeralan S, Leehey D, McBurney C, Jain A, Park T, Broadwater L, El-Serag H, Shaib Y, Taylor E, Nair P, Broussard E, Gibson E, Hawkins R, Natividad T, Courtade D, Palmer M, Martinez S, Panagiotis K, Morrow C, Ballard C, Barker B, Garner M, McCalley S, Schwartzkopf A, Wright A, Titi M, Higbee A, Pratiksha S, Jones A, Shipe T, McKee J, Vennalaganti R, Terrey K, Maruf L, Brown D, Crouse E, Marchant-Miros K, Ussery B, Ducker L, Estell J, Porchia S, Kim M, Kim C, Chan B, Hayton A, Christiansen H, Peterson M, Ding G, Simpson V, Read S, Mamani G, Salazar J, Kato J, Bowie M, Carnevale R, Halim M, Sahagian A, Ibarra A, Travis Z, Garcia J, Gill A, Starzyk J, Sumarli S, Johnson V, Peresuh S, Quimby T, Cordova R, Herold L, Hawley A, Goo T, Kidao J, Lee R, Freidel C, Gutierrez E, Noorisharghi N, Ivie G, Jawish T, Partin S, Yoo G, Fabilane C, Noori N, Lang E, Senen S, Partin S, Fathi M, Chauvin R, Feiger J, Reataza M, Morgan T, Asghar A, Jacobs J, Kashefi M, May F, Ohning G, Padua D, Smutko V, Oh D, Kosoyan H, Dreskin B, Luu K, Alas A, Bharath P, Dixit V, Sanford** D, Vu J, Kadi S, Nwajuaku T, Smith J, Kincaid J, Mir M, Lanceta J, Rice J, Agarwal P, Augustine A, Prickel H, Vue J, Guerrero K, Levenson S, Aguilera-Fish A, Chestnut L, Jobse B, Lombardo C, Silver T, Ahmed N, Bockhold K, Koppelman R, Carneiro F, Garcia-Morales R, Spector D, Gomez J, Lehenbauer K, Reinink A, Anway R, Evans-Lindquist M, Eggers T, Green M, Pretti A, Meyeraan T, Condon D, Cavanagh M, DeFalco C, Cutting J, Joseph K, Dean S, Mitchell S, Phillips V, Krueger C, Zink D, Goldberg K, Patel N, Martinez Gonzalez M, Davis-Underwood H, O'Sullivan A, Suppes T, Bratcher K, Stern D, Wu R, Damisa J, Warsi R, Nguyen T, Pinillos H, Flowers E, Kuramoto A, Thurmond C, Orozco L, Farrell G, Jaynes R, Saenz P, Perez C, Collins J, Lin E, Onstad L, Pitts A, Osborn K, Kenworthy-Heinige T, Casey A, Gold D, Olivo C, Joos S, Subramanian S, Forro V, Cannady A, Usih J, Raitt M, Flynn M, Shittu Y, Jawaid M, Anderson R, Poole D, Butler C, Snead L, Christine H, Swanson G, Heumann D, Pandak W, Spataro J, Bajaj J, Solomon C, Smith Gilles H, Zafass A, Tilak S, Fuchs M, Davis M, Blackman L, Lemler J, Munsey R, Deebo J, McCarthy J, Noel M, Hurley R, Zurowski W, Sharpe A, Wilson K, Peets R, Lorenso B, Burrison S, Johnson D, Angelovic A, Erickson N, Hanson H, Bailey T, Genung K, Dulin H, Neuharth R, Clegg D, Velarde K, Dever J, Murphy M, Beck D, Wasil M, Vazquez J, O'Neil E, Ganji G, Ducom J, Lee M, Hovespians R, Margolis J, Simmons B, Sweeney (formerly St. Martin) J, Henry R, Martin-Ortiz J, Santiago-Rivera L, Gonzalez - Aviles G, Pedrosa C, Bird-Caceres J, Padilla B, Baez-Corujo F, Martinez- Ortiz Y, Vazquez E, Grigg-Gutierrez N, Laboy-Olivieri C, Urbina-Velez R, Andrews S, Rosa-Cruz S, Tirado-Montijo R, Otero-Aponte K, Martinez-Martino M, Freire A, Soto-Ramos A, Santana-Perez M, Araujo J, Vanderwarker C, Alexander J, Nevins E, LaGuire J, Guerrero L, Piehl G, Jenkins M, Chen T, Jang J, Tanus A, McKelvy P, Sayuk G, Chandiramani P, Vargo (Formerly Shoults) L, Vargo K, Lawrence S, Blythe K, Goldsmith S, Campbell R, Craddock M, Amodeo D, Reinhard R, Durant B, Wells B, Zoble A, Papademetriou M, Roche N, Adler P, Krishna A, Glaze D, Wijegunawardana D, Yeroushalmi S, Laine L, Mautner R, Bugaj J, Anderson J, Croteau H, Kingman L, Burridge L. Baseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial. JAMA Network Open 2023, 6: e2321730. PMID: 37432690, PMCID: PMC10336619, DOI: 10.1001/jamanetworkopen.2023.21730.Peer-Reviewed Original ResearchConceptsFecal immunochemical testImmunochemical testEligible individualsAnnual fecal immunochemical testColorectal Cancer Screening TrialScreening testVeterans Affairs Medical CenterAverage CRC riskCancer Screening TrialCancer mortality outcomesCross-sectional studySpecific screening testCase report formsColorectal Cancer StudyStudy participant characteristicsCross-sectional analysisStool testingCRC riskMortality outcomesColorectal cancerClinical trialsCONFIRM studyMedical CenterScreening preferencesHispanic ethnicity
2022
Facilitating future implementation and translation to clinical practice: The Implementation Planning Assessment Tool for clinical trials
Kowalski C, Kawentel L, Kyriakides T, Davis L, Bowersox N, Kilbourne A, Huang G, Nevedal A. Facilitating future implementation and translation to clinical practice: The Implementation Planning Assessment Tool for clinical trials. Journal Of Clinical And Translational Science 2022, 6: e131. PMID: 36590355, PMCID: PMC9794955, DOI: 10.1017/cts.2022.467.Peer-Reviewed Original ResearchClinical trialsVeterans Health Administration OfficePost-trial implementationRoutine care settingsClinical research programCooperative Studies ProgramImplementation science principlesAssessment toolCare settingsTrial completionClinical trialistsClinical practiceEffective interventionsTrial resultsInterventionImplementation scienceResearch protocolTrialsOne-fifthRigorous data collectionOverwhelming naturePatientsTrialists
2021
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment
Drekonja DM, Shaukat A, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment. Clinical Trials 2021, 18: 622-629. PMID: 34154439, DOI: 10.1177/17407745211021198.Peer-Reviewed Original ResearchConceptsClinical trialsCase identificationRecurrent infectionsIndividuals meeting inclusion criteriaVeterans Affairs Corporate Data WarehouseFrequent antimicrobial usePrevention of recurrentRecurrent Clostridioides difficileSuccessful initial treatmentFecal microbiota transplantationIncidence of recurrentVeterans Affairs systemFecal microbiota transplantNationwide clinical trialMeeting inclusion criteriaQuality of lifeCorporate Data WarehouseTransplant administrationPrimary endpointStandard therapySubstantial morbidityInitial treatmentCapsule administrationMicrobiota transplantationRandomized comparison258 THE ASSOCIATION OF RACE AND ETHNICITY ON PRIOR COLORECTAL CANCER SCREENING TEST USE IN A LARGE CLINICAL TRIAL OF US VETERANS
Robertson D, Dominitz J, Beed A, Williams A, Boardman K, Imperiale T, Lieberman D, Provenzale D, Shaukat A, Sultan S, Kyriakides T. 258 THE ASSOCIATION OF RACE AND ETHNICITY ON PRIOR COLORECTAL CANCER SCREENING TEST USE IN A LARGE CLINICAL TRIAL OF US VETERANS. Gastroenterology 2021, 160: s-59-s-60. DOI: 10.1016/s0016-5085(21)00886-6.Peer-Reviewed Original Research
2020
An Application of the Cure Model to a Cardiovascular Clinical Trial
Sevilimedu V, Ma S, Hartigan P, Kyriakides T. An Application of the Cure Model to a Cardiovascular Clinical Trial. Statistics In Biosciences 2020, 13: 402-430. DOI: 10.1007/s12561-020-09297-w.Peer-Reviewed Original ResearchMyocardial infarctionACS eventAggressive Drug Evaluation (COURAGE) trialClinical Outcomes Utilizing RevascularizationHazard of MICardiovascular clinical trialsDrug evaluation trialsCoronary syndromeClinical trialsMedical conditionsClinical practiceSurvival analysisCure modelNovel findingsRiskTrialsCured fractionEvaluation trialsRevascularizationInfarctionSyndrome
2019
Analysis of the Impact of Antiretroviral Drug Changes on Survival of Patients with Advanced-Stage AIDS with Multidrug-Resistant HIV Infection
Ma R, Jung TH, Peduzzi PN, Brown ST, Kyriakides TC. Analysis of the Impact of Antiretroviral Drug Changes on Survival of Patients with Advanced-Stage AIDS with Multidrug-Resistant HIV Infection. Journal Of The International Association Of Providers Of AIDS Care (JIAPAC) 2019, 18: 2325958219849101. PMID: 31272313, PMCID: PMC6748500, DOI: 10.1177/2325958219849101.Peer-Reviewed Original ResearchConceptsDrug changesCox proportional hazards regression modelKaplan-Meier survival techniqueMultidrug-resistant HIV infectionProportional hazards regression modelsAdvanced-stage AIDSDrug regimen changesSurvival of patientsHazards regression modelsAntiretroviral clinical trialsClinical biomarker dataCause mortalityMedication changesARV regimenHIV infectionImproved survivalRegimen changeClinical outcomesNonclinical reasonsClinical trialsBiomarker changesTreatment historyMultidrug resistanceTherapy strategiesPatients
2018
Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial
Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS And Behavior 2018, 23: 211-221. PMID: 30073637, PMCID: PMC6476298, DOI: 10.1007/s10461-018-2241-z.Peer-Reviewed Original ResearchConceptsHIV-positive patientsHeavy drinking daysVACS Index scoreXR-NTXART adherenceDrinking daysIndex scoreUndetectable HIV viral loadCD4 cell countExtended-release naltrexoneDouble-blind placeboHIV viral loadRandomized-controlled trialDrinking outcomesHIV biomarkersSecondary outcomesHIV outcomesPrimary outcomeViral loadAntiretroviral adherenceClinical trialsCell countAlcohol treatmentHIVPatientsEffect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial
Davis LL, Kyriakides TC, Suris AM, Ottomanelli LA, Mueller L, Parker PE, Resnick SG, Toscano R, Scrymgeour AA, Drake RE. Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry 2018, 75: 316-324. PMID: 29490371, PMCID: PMC5875356, DOI: 10.1001/jamapsychiatry.2017.4472.Peer-Reviewed Original ResearchConceptsPosttraumatic stress disorderClinical trialsIPS groupIndividual PlacementVeterans Affairs Medical CenterCompetitive jobsStress disorderChronic posttraumatic stress disorderVocational rehabilitation interventionsVocational rehabilitationCompetitive employmentMore participantsTreat analysisMean ageMedical CenterMAIN OUTCOMERehabilitation interventionsMultisite trialLatino ethnicityIPS participantsSupported employment interventionTransitional workTrialsVeterans
2017
Principles of Analysis
Johnson G, Kyriakides T. Principles of Analysis. 2017, 151-162. DOI: 10.1007/978-3-319-53877-8_17.Peer-Reviewed Original Research
2016
Long-term Cost-effectiveness in the Veterans Affairs Open vs Endovascular Repair Study of Aortic Abdominal Aneurysm: A Randomized Clinical Trial
Lederle FA, Stroupe KT, Kyriakides TC, Ge L, Freischlag JA. Long-term Cost-effectiveness in the Veterans Affairs Open vs Endovascular Repair Study of Aortic Abdominal Aneurysm: A Randomized Clinical Trial. JAMA Surgery 2016, 151: 1139-1144. PMID: 27627802, DOI: 10.1001/jamasurg.2016.2783.Peer-Reviewed Original ResearchConceptsAbdominal aortic aneurysmOpen repair groupEndovascular repairHealth care costsClinical trialsEndovascular groupRepair groupTotal mean health care costsCare costsVeterans Affairs Medical CenterMean health care costsEndovascular repair proceduresInitial endovascular repairAortic abdominal aneurysmQuality of lifeHealth care servicesElective repairClinical outcomesInitial repairShorter hospitalizationAbdominal aneurysmSecondary proceduresAortic aneurysmMAIN OUTCOMEMedical Center
2010
Methodological Issues in Comparative Effectiveness Research: Clinical Trials
Peduzzi P, Kyriakides T, O'Connor TZ, Guarino P, Warren SR, Huang GD. Methodological Issues in Comparative Effectiveness Research: Clinical Trials. The American Journal Of Medicine 2010, 123: e8-e15. PMID: 21184867, DOI: 10.1016/j.amjmed.2010.10.003.Peer-Reviewed Original ResearchConceptsComparative effectiveness clinical trialEffectiveness clinical trialClinical trialsVeterans Affairs Cooperative Studies ProgramCooperative Studies ProgramComparative effectiveness researchMechanism of actionUsual careDiabetes mellitusRheumatoid arthritisFuture trialsClinical equipoisePatient preferencesRisk factorsNeurologic disordersInfectious diseasesMental healthTrialsDisease areasEffectiveness researchPharmaceutical issuesType of studyValid comparisonsMellitusArthritis
2007
Evolution of Genotypic Resistance Algorithms and Their Impact on the Interpretation of Clinical Trials: An OPTIMA Trial Substudy
Desai S, Kyriakides T, Holodniy M, Al-Salman J, Griffith B, Kozal M. Evolution of Genotypic Resistance Algorithms and Their Impact on the Interpretation of Clinical Trials: An OPTIMA Trial Substudy. HIV Research & Clinical Practice 2007, 8: 293-302. PMID: 17956830, DOI: 10.1310/hct0805-293.Peer-Reviewed Original ResearchConceptsLong-term clinical trialsGenotypic resistance algorithmsClinical trialsDisease progressionHIV disease progression ratesHIV-1 pol sequencesHIV disease progressionDisease progression rateResistance algorithmsVirologic responseDrug comparisonsProgression rateVirtual phenotypeGenotypic algorithmsPol sequencesPatientsDrug resistanceResistance interpretationTrialsProgressionDrugsExpected ratesViral sequencesFirst eventSimilar time
2003
An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial
Kyriakides TC, Babiker A, Singer J, Cameron W, Schechter MT, Holodniy M, Brown ST, Youle M, Gazzard B, Team O. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. Contemporary Clinical Trials 2003, 24: 481-500. PMID: 12865041, DOI: 10.1016/s0197-2456(03)00029-1.Peer-Reviewed Original ResearchConceptsOPTIMA trialClinical trialsTherapeutic strategiesHuman immunodeficiency virus-infected individualsVirus-infected individualsDrug-free periodVeterans Affairs hospitalDifferent therapeutic strategiesYears of intakeNovel therapeutic strategiesAnti-HIV drugsAntiretroviral therapyStrategy armART drugsTrial designHIV drugsStudy durationHospitalTrialsRelative efficacyDrugsTherapyOptimum trial designYearsMulticenter