Clinical Infectious Diseases, February 2022.
The MOXIE trial (A5366) is the first cure study designed specifically to enroll women. The study tested whether blocking estrogen would make a latency reversal agent (LRA) more effective. This question is important because estrogen may impact HIV latency and may have consequences for curative interventions. In MOXIE, 31 cisgender, post-menopausal women on antiretroviral therapy (ART) enrolled in the trial and were split into two groups. One group received tamoxifen, a medication that blocks estrogen, and the other group took no new medications. All of the women then received two doses of the latency reversal agent vorinostat and levels of HIV expression were measured in their blood. The study did not show a benefit of tamoxifen but did show that a marker of the effect of vorinostat (histone acetylation) varied a great deal and was related to levels of HIV RNA.
The question of whether estrogen is important for cure, in particular among premenopausal women, remains unanswered. But MOXIE demonstrated the potential to explore these important questions in women living with HIV and showed that women are engaged and ready to participate in interventional cure trials.
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