Drug-Drug Interaction Study in Trans Women Living With HIV
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Introduction: Transgender (trans) women have been found to be at higher risk of and to be
disproportionally affected by HIV. Trans women with HIV have also been found to have low
usage and adherence rates to antiretroviral therapy (ART). Both healthcare providers and
trans women, themselves, have expressed concerns of drug-drug interactions (DDIs) between ART
drugs and feminizing hormones, which have in turn been shown to contribute to low rates of
ART usage amongst trans women with HIV. The objective of this DDI study is to investigate the
pharmacokinetic effects of the common feminizing hormone regimens (oral estradiol with an
anti-androgen (pharmaceutical and/or surgical and/or medical) on the antiretroviral
combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and vice versa.
Methods and Analysis: Participants will be assigned to three groups: group 1 will include 15
trans women with HIV who are taking feminizing hormones and ART (investigational group);
group 2 will include 15 premenopausal cis women with HIV taking ART (ART control group);
group 3 will include 15 trans women without HIV taking feminizing hormones (hormone control
group). Women with HIV will have to be virally suppressed for at least three months and they
will have to already be taking B/F/TAF or have their current ART regimen switched to B/F/TAF
at baseline. Trans women participants will be required to be on 2 mg oral estradiol or higher
and an anti-androgen (pharmaceutical, medical or surgical). Plasma ART drug concentrations
will be sampled at the 2-month visit and compared among trans women with HIV on feminizing
hormones and premenopausal cis women with HIV. Serum estradiol and total testosterone
concentrations will be sampled at the baseline and month 2 visits and compared among trans
women with and without HIV. If successful, this trial will serve to provide empirical
evidence regarding a lack of, or presence of DDIs between B/F/TAF and feminizing hormones.
Dissemination: The findings will be disseminated through publication in peer-reviewed
journals as well as presented at national and international conferences and community groups.