CompletedPhase 2

Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum

Malawi, South Africa, Uganda780 participantsStarted 2018-07-03

Plain-language 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 daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants.

Who can participate

Age range

16 Years – 24 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 parti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimated Threshold of Maternal Steady-state Tenofovir Diphosphate (TFV-DP) Concentration Levels Corresponding to Optimal Adherence in the PK Component

Timeframe: Measured from study week 1 to study week 12 during pregnancy for Maternal PK Component Group 1 and from study week 1 to study week 12 during postpartum for Maternal PK Component Group 2

Proportion of Mothers With Optimal Adherence at Antepartum Study Week 4

Timeframe: Antepartum study week 4

Proportion of Mothers With Optimal Adherence at Antepartum Study Week 8

Timeframe: Antepartum study week 8

Proportion of Mothers With Optimal Adherence at Antepartum Study Week 12

Timeframe: Antepartum study week 12

Proportion of Mothers With Optimal Adherence at Delivery

Timeframe: Delivery

Proportion of Mothers With Optimal Adherence at Postpartum Week 6

Timeframe: Postpartum Week 6

Trial details

NCT IDNCT03386578

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-10-25

Results submitted2024-10-24

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