Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1

NCT06435026 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 22-2056R01AI157859
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 2

Brief Summary

This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the maternal and infant safety of increased FTC/TDF doses during these periods.

Conditions

HIV; Prevention; Pregnancy

Keywords

HIV; PrEP; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs)

  AUC of TFV-DP

  Up to 20 weeks after delivery

Secondary Outcomes (2)

• Maternal grade >/= 2 adverse events

  Up to 20 weeks after delivery

• Adverse pregnancy outcomes

  At time of delivery

Study Arms (3)

Standard Dose

OTHER

daily oral FTC/TDF standard dose (200mg/300mg, n=18)

Drug: FTC/TDF 200mg/300mg

150% standard dose

OTHER

daily oral FTC/TDF dose (300mg/450mg, n=18),

Drug: FTC/TDF 300mg/450mg

200% standard dose

OTHER

daily oral FTC/TDF (400mg/600mg, n=18)

Drug: FTC/TDF 400mg/600mg

Interventions

FTC/TDF 200mg/300mg DRUG

Standard Dose

Also known as: PrEP

Standard Dose

FTC/TDF 300mg/450mg DRUG

150% Standard Dose

Also known as: PrEP

150% standard dose

FTC/TDF 400mg/600mg DRUG

200% Standard Dose

Also known as: PrEP

200% standard dose

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal participants:
• Aged 16 years or older
• PrEP-eligible by local guidelines
• Pregnant with a viable singleton pregnancy of between 14 and 23 completed weeks of gestation (from 14 weeks + 0 days to 23 weeks + 6 days) by ultrasonography at study entry
• HIV-negative based on the study-specific screening algorithm
• Hepatitis B surface antigen (HBsAg)-negative
• Weight \>35 kg
• Provided informed consent and expressed willingness to participate in study activities with their infants, including daily administration of oral PrEP under direct observation
• Infant participants:
• Infant participants enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise. If an infant is deemed too ill to undergo study procedures, procedures necessary for clinical management may be prioritized.

You may not qualify if:

• Maternal participants will not enter the study if any of the following conditions are identified during the screening process:
• Grade 2 or greater laboratory parameters for alanine transaminase (ALT) or aspartate aminotransferase (AST), hemoglobin (HB), and absolute neutrophil count (ANC).
• Estimated creatinine clearance (CrCl) 90 mL/min or below, using the Cockcroft-Gault formula.
• Known history or evidence of current significant disease process, including: hematological conditions, renal disease, unexplained bone fractures, environmental enteric dysfunction, or allergies/sensitivities to FTC/TDF.
• Other current significant or uncontrolled disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator, would make participation in the study inappropriate or unsafe.
• Fetuses with known or suspected major fetal anomaly, either from screening ultrasound or via medical record
• Intention to leave the study site's catchment area before scheduled study exit.
• Current use of prohibited medications
• Concurrent use of other biomedical HIV prevention interventions (vaginal ring, injectable PrEP, any investigational prevention product).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (2)

Bwaila District Hospital

Lilongwe, Malawi

Location

Seke North CRS

Harare, Zimbabwe

Location

Study Officials

• Benjamin Chi, MD, MSc

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lynda Stranix-Chibanda, MBChB, MMed

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

• Peter Anderson, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: June 18, 2024
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

MA (1); ZI (1)