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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    390
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 5 March 2022
tenofovir
emtricitabine
pre-exposure prophylaxis (prep)
hepatitis
HIV Vaccine
drug levels
emtricitabine/ tenofovir disoproxil fumarate
acute hiv infection
drug level
Accepts healthy volunteers

Summary

The purpose of this study is 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.

Description

This study will evaluate 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 infants. The study will be conducted in two consecutive components: 1) Pharmacokinetics (PK) Component and 2) PrEP Comparison Component.

In the PK Component, women will be enrolled in one of two groups. Group 1 will include antepartum women at 14 to 24 weeks' gestation and Group 2 will include postpartum women who delivered 6 to 12 weeks prior to enrollment. Both groups will receive a fixed-dose combination of FTC/TDF administered once daily from Day 0 through Week 12.

In the PrEP Comparison Component, women will be enrolled in one of two cohorts. Participants in both Cohorts 1 and 2 will receive a behavioral HIV risk reduction package, including cohort-appropriate short message service (SMS) messages from Day 0 through Week 26. Cohort 1 will also receive daily oral FTC/TDF as PrEP from Day 0 through Week 26 and enhanced adherence support, including SMS messaging and feedback of drug levels with tailored counseling.

Mothers in the PK Component will have weekly study visits through Week 12 to be evaluated for drug levels and monitored for adverse effects, with their infants. Mothers in the PrEP Comparison Component will have several study visits through Week 26 (post-partum). Infants in the PrEP Comparison Component will have four study visits from birth through week 26 of life. For mothers, study visits may include physical examinations, blood and urine collection, vaginal and rectal swab collection, vaginal secretions collection, ultrasounds, and dual-energy x-ray absorptiometry (DXA) scans. For infants, study visits may include physical examinations, rectal swab and blood collection, and DXA scans.

Details
Condition HIV Infections
Treatment Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package
Clinical Study IdentifierNCT03386578
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

At study entry, mother is 16-24 years of age
For mothers who are of legal age to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: The mother is willing and able to provide written informed consent for her and her infant's study participation
For mothers who are not of legal age to provide independent informed consent. The parent/guardian or other legally authorized representative of the mother and her infant is willing and able to provide written informed consent for the mother and her infant's study participation; in addition, when applicable the mother is willing and able to provide written assent for her and her infant's study participation
At screening, evidence of a viable singleton pregnancy with gestational age of 32 weeks or less, defined as 224 days or less after the date of conception with sonographic confirmation. Note: if adequate sonographic results are not available from medical records at screening, an ultrasound must be performed in the interim so that the result is available at study entry
Within 14 days prior to study entry, negative by HIV RNA test
At study entry, HIV rapid test negative and absence of symptoms of acute HIV infection (i.e. acute viral illness)
At screening, Hepatitis B negative by Hepatitis B surface antigen test performed
At screening, has the following laboratory test results
Grade 1 or normal (less than 2.5 x ULN) ALT
Grade 1 or normal (greater than or equal to 9.5 g/dL) HB
Grade 1 or normal (greater than or equal to 800 cells/mm^3) ANC
Normal (greater than or equal to 90 mL/min) for estimated creatinine clearance (CrCl; Cockcroft-Gault formula)
At screening, mother has negative or trace proteinuria (less than Grade 1)
At screening, mother has normal dipstick urine for glucose (less than Grade 1)
Intention to stay within the study site's catchment area through 26 weeks postpartum
Regular access to a cellular phone that is able to receive short message service (SMS) messages, and for Cohort 1 only, is also able to send SMS messages
Cohort 1 only: At study entry, expresses willingness to take PrEP from pregnancy up to 26 weeks postpartum
Cohort 2 only: At study entry, expresses unwillingness to take PrEP from pregnancy up to 26 weeks postpartum
At study entry, mother weighs greater than 35 kg
Based on site investigator assessment at screening, mother is literate in one or more of the study languages

Exclusion Criteria

Mother has any current significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate
Mother has a known history of any of the following, as determined by the site investigator or designee based on maternal report and available medical records
Sickle cell anemia (excluding sickle cell trait), chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) 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, from chart review of prior data, defined as a structural malformation with surgical, medical, or cosmetic importance
Mother has confirmed renal insufficiency, a history of known renal parenchymal disease, or known single kidney at screening
Current use of prohibited medications listed in the protocol
Concurrent participation in a study of any biomedical HIV prevention intervention or investigational drug in an HIV vaccine study 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 that, in the opinion of the site investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Past participation in IMPAACT 2009
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