CT183/2019 MTN-042

Primary Sponsor Details

Secondary Sponsor Details

South Africa

Malawi 

Uganda

Zimbabwe

• • Age 18 through 40 years
  • Evidence of a viable, intrauterine, singleton pregnancy with sonographic confirmation, including for gestational age assessment.
  • At Enrollment, pregnancy within gestational age limits of the currently enrolling cohort
  • HIV-uninfected based on testing performed at Screening and Enrollment
  • Intending to continue her pregnancy until delivery.
  • Intending to deliver at a health center or hospital where adequate records may be obtained, as defined in site SOPs.
  • Willing to be randomized at time of enrollment to either of the two study arms, and to continue study product use until delivery.
  • Able and willing to comply with all study requirements and complete all study procedures.

Participants who meet any of the following criteria will be excluded from this study:

• Use oral PrEP outside the context of study participation.
• Relocate away from the study site.
• Travel away from the study site for a time period that would interfere with study participation.
• At screening or Enrollment, has a positive HIV test.
• At Screening or Enrollment, diagnosed with urinary tract infection (UTI), cervicitis, STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines.
• At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding.
• Cervical friability bleeding associated with speculum insertion
• Participant report, clinical evidence and/or antenatal/medical care record of any of the following:

1. Currently breastfeeding at Enrollment.
2. Known adverse reaction to any of the study products (ever).
3. Known adverse reaction to latex and polyurethane (ever).
4. Symptoms suggestive of acute HIV infection at Screening or Enrollment.
5. Non-therapeutic injection drug use in the 12 months prior to Enrollment.
6. Use of HIV post-exposure prophylaxis (PEP) and/or PrEP during the current pregnancy.
7. Paiticipation in any other research study involving drugs, medical devices, vaginal products, or vaccines during the current pregnancy.
8. At Screening or Enrollment, known to have any of the following during the current pregnancy:
   • Multiple gestation
   • Placenta previa
   • Cervical cerclage
   • Abnormal fetal anatomy (in the opinion of the IoR or designee)
   • Intrauterine growth restriction
   • Pre-existing or gestational diabetes
   • Hypertensive disorder of pregnancy
   • Severe malaria
   • Treatment for preterm labor
   • Abnormal quantity of amniotic fluid (oligohydramnios or polyhydramnios)
9. At Screening, known to have had any of the following in a previous pregnancy:
   • Intrauterine growth restriction
   • Gestational diabetes
   • Hypertensive disorder of pregnancy
   • Intrauterine fetal demise (estimated gestational age ≥20 weeks)
   • Delivery prior to 37 0/7 weeks

10. At Enrollment has any significant obstetrical complication or uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease that would make study participation unsafe.

• Has any of the following laboratory abnormalities:
  • Positive for hepatitis B surface antigen (HBsAg).
  • Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥: Grade 1.
  • Hemoglobin ≥ Grade 2.
  • Platelet count ≥ Grade I.
  • Creatinine ≥ Grade I.
  • Estimated creatinine clearance 2 ≥ Grade I (Cockcroft Gault formula).
  • Glycosuria ≥ Grade 2.
  • Proteinuria ≥ Grade 2.
• Has any condition that, in the opinion of the loR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Maternal Safety (Composite)

• All serious adverse events, including maternal deaths
• All grade 3 or higher AEs as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adversee Events, Corrected Version  2.1, July 2017  and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [ Dated November 2007]

Infant Safety (Composite)

• All serious adverse events, including infant deaths and congenital anomalies
• All Grade 3 or higher AEs as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Pregnancy Outcomes

• Frequency of the following pregnancy outcomes:
  • Full term live birth (≥37 weeks)
  • Premature live birth (< 37 weeks) 
  • Pregnancy loss (≥20 weeks)
  • Pregnancy loss (<20 weeks)

9.0 DESIGN OF THE TRIAL

If controlled