SSAT063- PK of EFV 400mg once daily during pregnancy in HIV+ women
Research type
Research Study
Full title
SSAT063; Pharamcokinetics of efavirenz 400mg once daily during pregnancy in HIV-1 infected women
IRAS ID
179230
Contact name
Marta Boffito
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2014-002615-42
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
The purpose of the study is to measure the drug levels in your blood and to find out whether a reduced dose (400mg) of the anti HIV medication efavirenz is safe when taken during pregnancy.
The study will recruit HIV infected women who take efavirenz as part of their anti-HIV treatment and who are pregnant.
We know that efavirenz is safe in pregnancy and that, at the standard dose that everybody takes of 600mg once a day, it shows levels that are enough to treat HIV and give birth to a HIV negative baby
Efavirenz at a dose of 400 mg once daily works against HIV too but this dose has not been given to HIV positive pregnant women
People with HIV may benefit from using a dose of efavirenz of 400 instead of 600, as lower drug doses could have fewer side effects and be tolerated better.
Dose reduction would also make the drug cheaper. This would allow more people to be treated and free up money for other important work in the fight against HIV such as education and prevention programs.
However, it is not known whether 400 mg of efavirenz works as well as 600mg of efavirenz during pregnancy and this is why we conducting this study, which aims to measure the amount of efavirenz 400 mg in your body when you are taking 400mg of efavirenz once a day .
If you consent to join, you will participate in the study for approximately 24 weeks, from your third trimester until approximately 8 weeks after the birth.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0904
Date of REC Opinion
16 Jun 2015
REC opinion
Favourable Opinion