Status:
WITHDRAWN
Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)
Lead Sponsor:
Johns Hopkins University
Conditions:
Pregnancy
HIV-1-infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery ...
Detailed Description
Study participants will be randomized to one of two parallel study arms, involving dosing of tenofovir disoproxil sodium/emtricitabine (TDF/FTC). The investigators will be recruiting and enrolling in ...
Eligibility Criteria
Inclusion
- age 18 years or older
- Able to speak English, French, or Spanish
- Able and willing to provide written informed consent
- Viable first (preferable) or second trimester intrauterine pregnancy
- Creatinine clearance \>70 ml/min
- Negative HIV test and no signs/symptoms of acute HIV infection,
- Documented negative hepatitis B virus status.
Exclusion
- HIV positive at any time in the study. All neonates of mothers participating in the trial will be recruited, regardless of gestational age at delivery or congenital anomalies/comorbidities.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03834909
Start Date
April 1 2022
End Date
April 1 2028
Last Update
April 6 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.