NCT06435026

CompletedPhase 2

Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan A...

University of North Carolina, Chapel Hill Source

University of North Carolina, Chapel Hill

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

22-2056

Secondary identifiers

R01AI157859

NIH

Study Type

interventional

Actual enrollment (reported)

54

Locations

2 countries

Sites

2

Timeline

Study Start

June 18, 2024

Actual (reported)

Primary Completion

February 11, 2026

Actual (reported)

Study Completion

February 11, 2026

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 54 participants
Study completion date: February 11, 2026
Actual (reported)
Listed locations: 2 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 20, 2024
Actual (reported)
First Posted
May 30, 2024
Actual (reported)
Study Start
June 18, 2024
Actual (reported)
Primary Completion
February 11, 2026
Actual (reported)
Study Completion
February 11, 2026
Actual (reported)

Last Updated: February 17, 2026
Status Verified: February 2026
Last Update Submitted: February 13, 2026

Conditions

HIV Pregnancy Prevention

Keywords

HIVPrEPPregnancy

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/300mgDrug

Standard Dose

Also known as: PrEP

Standard Dose

FTC/TDF 300mg/450mgDrug

150% Standard Dose

Also known as: PrEP

150% standard dose

Eligibility Criteria

Age16 Years+

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsPregnant women

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Maternal participants:

Sponsors & Collaborators

University of North Carolina, Chapel Hill
Otherlead
National Institute of Allergy and Infectious Diseases (NIAID)
NIHcollaborator

Study Sites (2)

Bwaila District Hospital

Lilongwe, Malawi

Seke North CRS

Harare, Zimbabwe

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

Enrollment

54 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 30, 2024

Study Start

June 18, 2024

Actual (reported)

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Phase 2Withdrawn

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Phase 2Completed

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Phase 2Not Yet Recruiting

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Phase 2Completed

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FTC/TDF 400mg/600mgDrug

200% Standard Dose

Also known as: PrEP

200% standard dose

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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).

Contact the study team to confirm eligibility.

Primary Completion

February 11, 2026

Actual (reported)

Study Completion

February 11, 2026

Actual (reported)

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.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06435026
Data provider: ClinicalTrials.gov
Source updated: 2026-02-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:42 UTC

Documents

Informed Consent Form
ICF2025-12-01

Locations

MW(1)ZW(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

Standard Dose

150% standard dose

200% standard dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations