SSAT063- Pharmacokinetics of Efavirenz 400 mg Once Daily During Pregnancy in HIV-1 Infected Women
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|ClinicalTrials.gov Identifier: NCT02499874|
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : October 20, 2017
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.
Efavirenz has been shown to be safe in pregnancy and 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 400mg 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 400mg instead of 600mg, 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 400mg of Efavirenz works as well as 600mg of Efavirenz during pregnancy and this is why the investigators are conducting this study, which aims to measure the amount of Efavirenz 400mg in HIV pregnant women's bodies when they are taking 400mg of Efavirenz once a day.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Efavirenz Drug: tenofovir /emtricitabine Drug: tenofovir/lamivudine Drug: lamivudine/zidovudine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of EFV 400mg Once Daily During Pregnancy in HIV+ Women|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||October 5, 2017|
|Actual Study Completion Date :||October 5, 2017|
Experimental: Single treatment arm
All subjects will be administered oral Efavirenz 400mg together with the rest of the oral antiretroviral combination (tenofovir 245 mg/emtricitabine 200mg or tenofovir 245mg/lamivudine 300mg or lamivudine 300mg/zidovudine 600mg) throughout the study period
oral Efavirenz 400mg
Other Name: Sustiva
Drug: tenofovir /emtricitabine
tenofovir 245 mg/emtricitabine 200mg
tenofovir 245mg/lamivudine 300mg
lamivudine 300mg/zidovudine 600mg
- Pharmacokinetics (AUC and Ctrough) of Efavirenz 400mg during pregnancy and postpartum. [ Time Frame: 24 weeks ]The pharmacokinetic parameters calculated for efavirenz will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h). Efavirenz pharmacokinetic parameters measure during the third trimester of pregnancy and postpartum will be compared by calculating geometric mean ratios and 90% confidence intervals.
- Safety and tolerability (based on physical examination, laboratory tests and the DIVISION OF AIDS (DAIDS) table for granding the severity of adult and and the pediatric adverse events of Efavirenz 400mg during pregnancy and postpartum [ Time Frame: 24 weeks ]Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
- Association between polymorphisms in drug disposition genes and exposure in order to understand whether polymorphism of certain genes encoding for efavirenz metabolic enzymes are behind differences in efavirenz pharmacokinetics between people [ Time Frame: 24 weeks ]candidate gene approach will be utilised to examine loci of interest. This procedure will provide potentially important information on genetic influences on plasma drug concentrations and give insight into how to improve the management of HIV-infected patients by individualising therapy. These studies will not be powered for genetic associations but will enable us to build a data base of genotype-phenotype. Prospective genetic studies would need to be planned based on these preliminary data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499874
|St Stephen's Centre, Chelsea and Westminster Hospital|
|London, United Kingdom|
|Principal Investigator:||Marta Boffito, MBBS,MD,PhD||St. Stephen's AIDS Trust|
|Principal Investigator:||Mohammed Lamorde, MBBS||Infectious Diseases Institute (IDI)|