Status:
COMPLETED
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
FEMALE
16-24 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral ...
Detailed Description
This study evaluated the pharmacokinetics, feasibility, acceptability, and safety of FTC/TDF as oral daily PrEP to prevent HIV during pregnancy and postpartum in adolescents and young women and their ...
Eligibility Criteria
Inclusion
- PK Component (Groups 1 and 2) Inclusion Criteria:
- At study entry, pregnant or recently delivered, in one of the following two enrollment windows:
- Group 1: Gestational age of 14 to 24 weeks.
- Group 2: 6 to 12 weeks postpartum.
- Willing to initiate daily PrEP for 12 weeks under directly observed therapy.
- HIV and Hepatitis B negative.
- At screening:
- Grade 1 or normal alanine transaminase (ALT), hemoglobin (HB), absolute neutrophil count (ANC) and normal creatinine clearance (CrCl).
- Negative or trace proteinuria (less than Grade 1).
- Normal dipstick urine for glucose (less than Grade 1).
- Mother weighs greater than 35 kg.
- Intention to stay within the study site's catchment area for at least 12 weeks (or through delivery).
- Exclusion Criteria (PK Component and PrEP Comparison Component):
- Any current significant uncontrolled, active or chronic disease process.
- History of any of the following:
- Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days or other blood dyscrasias
- Bone fracture not explained by trauma
- Allergy/sensitivity to FTC/TDF or its components
- Fetus has a known or suspected major congenital anomaly
- Mother has confirmed renal insufficiency, a history of renal parenchymal disease or single kidney
- Current use of prohibited medications listed in the protocol
- Concurrent participation in any biomedical HIV prevention or investigational drug in an HIV vaccine or microbicide study
- Past participation in an HIV vaccine study
- Currently taking a PrEP regimen from non-study sources
- Any other condition or adverse social situation
- Past participation in IMPAACT 2009
- PrEP Comparison Component (Cohorts 1 and 2) Inclusion Criteria:
- At screening, evidence of a viable singleton pregnancy with gestational age of 32 weeks or less.
- Within 14 days prior to study entry, negative HIV RNA test.
- HIV and Hepatitis B negative.
- At screening:
- Grade 1 or normal ALT, HB, ANC and normal CrCl.
- Negative or trace proteinuria (less than Grade 1).
- Normal dipstick urine for glucose (less than Grade 1).
- Intention to stay within the study site's catchment area through 26 weeks postpartum
- A cellular phone that is able to receive SMS messages, and for Cohort 1 only, is also able to send SMS messages.
- Cohort 1 only: Willingness to take PrEP from pregnancy up to 26 weeks postpartum
- Cohort 2 only: Unwillingness to take PrEP from pregnancy up to 26 weeks postpartum
- Mother weighs greater than 35 kg
- Mother is literate in one or more of the study languages
Exclusion
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2024
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT03386578
Start Date
July 3 2018
End Date
February 24 2024
Last Update
February 19 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Blantyre CRS
Blantyre, Malawi
2
Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, South Africa, 2001
3
Baylor-Uganda CRS
Kampala, Uganda
4
MU-JHU Care Limited CRS
Kampala, Uganda