Overview

Pharmacokinetic Effect of Evotaz/Microgynon Co-administration

Status:
Terminated
Trial end date:
2017-10-31
Target enrollment:
Participant gender:
Summary
This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
Phase:
Phase 1
Details
Lead Sponsor:
St Stephens Aids Trust
Collaborator:
Bristol-Myers Squibb
Treatments:
Atazanavir Sulfate
Cobicistat
Ethinyl Estradiol
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel