The first-ever HIV cure trial conducted exclusively in women, the MOXIE Trial concludes that tamoxifen did not augment vorinostat-induced HIV RNA expression in postmenopausal women. The investigators had hypothesized that estrogen receptor alpha (ESR1) antagonism would augment the induction of HIV expression by vorinostat, a latency reversal agent.
In 31 virologically suppressed postmenopausal women receiving antiretroviral therapy, primary endpoints were safety and the difference in HIV RNA induction between the intervention group receiving tamoxifen and an observation arm. Following 2 doses of vorinostat, results showed that tamoxifen did not enhance vorinostat-induced HIV transcription. Additionally, vorinostat-induced HIV transcription was higher in participants with increases in H4Ac. HIV DNA and single copy assay plasma viremia did not change.
“The modest latency reversal activity of vorinostat, postmenopausal status, and low level of HIV RNA expression near the limits of quantification limited assessment of the impact of tamoxifen,” the authors conclude. “This study is the first HIV cure trial done exclusively in women and establishes both the feasibility and necessity of investigating novel HIV cure strategies in women living with HIV.”