NCT03386578CompletedPhase 2
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants
Source: ClinicalTrials.gov · Last updated 19 Feb 2025
Brief summary (registry, in English)
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 daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 780 (actual)
- First submitted
- 18 Dec 2017
- Start date
- 3 Jul 2018
- Primary completion date
- 25 Oct 2023
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- HIV
- NCT number
- NCT03386578
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 780
- From 3 Jul 2018 to the primary completion date, 25 Oct 2023
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Currently taking a PrEP regimen from non-study sources
- Within 14 days prior to study entry, negative HIV RNA test.
Other illness
- 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
- Mother has confirmed renal insufficiency, a history of renal parenchymal disease or single kidney
- Past participation in an HIV vaccine study
- Any other condition or adverse social situation
- HIV and Hepatitis B negative.
Lab values
- 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).
Age
- At screening, evidence of a viable singleton pregnancy with gestational age of 32 weeks or less.
Other
- Fetus has a known or suspected major congenital anomaly
- Past participation in IMPAACT 2009
- PrEP Comparison Component (Cohorts 1 and 2) Inclusion Criteria:
- 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
Criteria the registry did not label
- 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).
Age in the registry: 16 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blantyre CRS Coordinator of this site? Confirm its status | Blantyre | Malawi | Unknown status |
| MU-JHU Care Limited CRS Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Baylor-Uganda CRS Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Wits RHI Shandukani Research Centre CRS Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Seke North CRS Coordinator of this site? Confirm its status | Chitungwiza | Zimbabwe | Unknown status |
| Harare Family Care CRS Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
| St Mary's CRS Coordinator of this site? Confirm its status | Saint Mary's | Zimbabwe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.