SSAT069: Pharmacokinetic effect of evotaz/microgynon co-administration
Research type
Research Study
Full title
The effect of atazanavir/cobicistat (evotaz®) on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel (microgynon 30®) in healthy women
IRAS ID
194138
Contact name
Marta Boffito
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2015-004799-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The purpose of this study is to look at the blood levels of the individual components of an anti-HIV medication combination and of a combined contraceptive pill when they are taken alone and when they are taken at the same time, in female healthy volunteers. The four components are atazanavir/cobicistat combined in Evotaz® used in HIV therapy and ethinylestradiol/levonorgestrel combined in Microgynon 30® used as contraception. The study will specifically look at blood levels of these four drugs when taken alone or together every day for 14 days. \nThere will be two groups. Participants in group 1 will take Microgynon 30® for 21 days followed by Microgynon30 (21 days) + Evotaz® (14 days) followed by Evotaz® for 14 days. Participants in group 2 will take Evotaz followed by Microgynon30 (21 days) + Evotaz® (14 days) followed by Microgynon 30® for 21 days. Steady state drug levels will be measured on days 14, 35 and 56 over 24hours. \nIf participants decide to take part, the duration of the study will be up to 57 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication.\nEligible subjects will be randomised (1:1 ratio) to group 1 or group 2. Participants and the study doctor will know which study medications the participant is taking at all times during the study.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0103
Date of REC Opinion
15 Apr 2016
REC opinion
Further Information Favourable Opinion