Pharmacology of Tenofovir Disoproxil Fumarate-Emtricitabine (TDF-FTC) Pre-exposure Prophylaxis in Kenyan Cisgender Wome
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202311518894272
- Lead Sponsor
- niversity of Washington
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 72
Inclusion criteria for the pregnant cohort
-Age =18 and =30 years
-HIV uninfected
-Has an active smart phone
-Normal renal function (GFR >60ml/min)
-Hepatitis B surface Ag negative
-High risk for HIV
-Pregnant at 13-26 weeks of gestation
-Willing to use DOT and come to clinic daily for DOT PrEP for 8 weeks
-Willing to have home visits/video streaming if clinic visit not feasible
Inclusion criteria for the non- pregnant cohort
-Age =18 and =30 years
-HIV uninfected
-Has an active smart phone
-Normal renal function (GFR >60ml/min)
-Hepatitis B surface Ag negative
-Low risk for HIV
-Not pregnant or breastfeeding
-Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP
-Willing to have home visits/video streaming if clinic visit not feasible
Exclusion criteria for pregnant women
-Inability to give informed consent
-HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician
-Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.
-Current or past use of PrEP (pre-exposure prophylaxis)
-Not willing to have home visit
-Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) or other blood dyscrasias
-Fetus has a known or suspected major congenital anomaly defined by fetal ultrasound.
Exclusion criteria for non-pregnant women
-Inability to give informed consent
-HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician
-Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.
-Current or past use of PrEP (pre-exposure prophylaxis)
-pregnancy/plan to become pregnant in the next 6 months/unwillingness to use birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Benchmark concentrations of TFV-DP in DBS and PBMCs, and the dosing frequency (i.e., doses per week) required to generate them. The goal is to quantify the effects of dose on steady state TFV-DP in DBS and PBMC based on an incomplete block design. We will use the observed week 8 concentrations for the dose-proportionality model. Week 8 is approximately 90% of steady state (3.3 * 17-day half-life = 8 weeks).
- Secondary Outcome Measures
Name Time Method -Examine models to predict non-daily adherence based on TFV/FTC and TFV-DP in DBS. We will first consider a saturated model allowing <br>a separate mean for each dose/adherence group. The results will then be compared to a reduced model with a class variable indicating non-daily dosing groups” or 100% dosing (that is, the effect of non-daily dosing” adherence does not differ by dose groups).