2020
Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy
Gonzales P, Grieco A, White E, Ding R, Ignacio RB, Pinto-Santini D, Lama JR, Altice FL, Duerr A. Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy. PLOS ONE 2020, 15: e0228433. PMID: 32134956, PMCID: PMC7058313, DOI: 10.1371/journal.pone.0228433.Peer-Reviewed Original ResearchConceptsAlcohol use disorderAntiretroviral therapyClinical adverse eventsAdverse eventsTransgender womenUse disordersDouble-blind randomized placebo-controlled trialMSM/transgender womenRandomized placebo-controlled trialART-naïve participantsPossibility of hepatotoxicityPlacebo-controlled trialSerious adverse eventsHIV-positive menMedication-assisted therapyProportion of subjectsAdverse event dataMultiple new medicationsOral naltrexoneStudy medicationTransaminase elevationPlacebo armNTX treatmentTreatment armsNew medications
2017
Corrigendum to ‘An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone’ [Journal of Substance Abuse Treatment 47 (2014) 35–40]
Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. Corrigendum to ‘An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone’ [Journal of Substance Abuse Treatment 47 (2014) 35–40]. Journal Of Substance Use And Addiction Treatment 2017, 77: 44. PMID: 28476270, PMCID: PMC5458355, DOI: 10.1016/j.jsat.2017.03.008.Peer-Reviewed Original ResearchRandomized placebo-controlled trialPlacebo-controlled trialExtended-release naltrexoneHepatic enzyme elevationRelease naltrexoneEnzyme elevationHIVNaltrexoneTrials
2014
An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone
Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. Journal Of Substance Use And Addiction Treatment 2014, 47: 35-40. PMID: 24674234, PMCID: PMC4042403, DOI: 10.1016/j.jsat.2014.02.008.Peer-Reviewed Original ResearchConceptsPlacebo-controlled trialXR-NTXGamma-glutamyl transferaseAlanine aminotransferaseMental illnessAspartate aminotransferaseRandomized placebo-controlled trialMonthly injectable formulationXR-NTX armExtended-release naltrexoneHepatic enzyme elevationHepatic enzyme levelsRelease naltrexoneAntiretroviral therapyHCV infectionBaseline characteristicsHepatic transaminasesEnzyme elevationPsychiatric medicationsHepatotoxicity concernsGlutamyl transferaseAlcohol dependenceOpioidsHIVNaltrexone