Unknown

Dataset Information

0

An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone.


ABSTRACT: Extended-release naltrexone (XR-NTX), an approved treatment for opioid or alcohol dependence, is a once-monthly injectable formulation of naltrexone. Hepatotoxicity concerns have limited its use, necessitating further investigation. This study aims to examine hepatic enzyme levels in participants of 2 randomized placebo-controlled trials (RCTs) of XR-NTX. Hepatic transaminases were measured in 85 patients enrolled in RCTs of XR-NTX among HIV-infected prisoners, transitioning to the community and receiving treatment for either dependence on alcohol (52.9%), opioids (44.7%) or both (16.5%). Baseline characteristics included HCV co-infection (55.7%), antiretroviral therapy (81%), mental illness (39%) and receiving psychiatric medications (34.1%). Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) were not statistically different between persons randomized to placebo (N=24) and XR-NTX (N=61) arms. These results confirm that XR-NTX is safe to use among opioid and alcohol dependent HIV-infected released prisoners receiving ART with high rates of co-morbid HCV infection and mental illness.

SUBMITTER: Vagenas P 

PROVIDER: S-EPMC4042403 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

altmetric image

Publications

An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone.

Vagenas Panagiotis P   Di Paola Angela A   Herme Maua M   Lincoln Thomas T   Skiest Daniel J DJ   Altice Frederick L FL   Springer Sandra A SA  

Journal of substance abuse treatment 20140312 1


Extended-release naltrexone (XR-NTX), an approved treatment for opioid or alcohol dependence, is a once-monthly injectable formulation of naltrexone. Hepatotoxicity concerns have limited its use, necessitating further investigation. This study aims to examine hepatic enzyme levels in participants of 2 randomized placebo-controlled trials (RCTs) of XR-NTX. Hepatic transaminases were measured in 85 patients enrolled in RCTs of XR-NTX among HIV-infected prisoners, transitioning to the community and  ...[more]

Similar Datasets

| S-EPMC5407009 | biostudies-literature
| S-EPMC5274608 | biostudies-literature
| S-EPMC3992862 | biostudies-literature
| S-EPMC4283549 | biostudies-literature
| S-EPMC5455014 | biostudies-literature
| S-EPMC5760469 | biostudies-literature
| S-EPMC6771097 | biostudies-literature
| S-EPMC5449233 | biostudies-literature
| S-EPMC7856237 | biostudies-literature
| S-EPMC5993595 | biostudies-literature