NCT03834909

Brief Summary

This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery (postpartum) to achieve study objectives which include PK, safety monitoring for maternal and fetal/infant safety signals, and adherence.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
23mo left

Started Apr 2022

Longer than P75 for phase_1 pregnancy

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Apr 2022Apr 2028

First Submitted

Initial submission to the registry

February 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 6, 2022

Status Verified

March 1, 2021

Enrollment Period

5.4 years

First QC Date

February 6, 2019

Last Update Submit

March 28, 2022

Conditions

PregnancyHIV-1-infection

Keywords

HIV PreventionHealthy Volunteer

Outcome Measures

Primary Outcomes (4)

  • Plasma Tenofovir (TFV) Concentration

    Plasma Tenofovir (TFV) Concentration in nanograms per milliliter (ng/mL)

    36 weeks

  • Plasma Emtricitabine (FTC) Concentration

    Plasma Emtricitabine (FTC) Concentration in nanograms per milliliter (ng/mL)

    36 weeks

  • Peripheral Blood Mononuclear Cell (PBMC) TFV-Diphosphate (TFV-DP)Concentration

    PBMC TFV-DP concentration in femtomoles/million cells (fmol/10E6 cells)

    36 weeks

  • Peripheral Blood Mononuclear Cell (PBMC) FTC-Triphosphate (FTC-TP)Concentration

    PBMC TFV-DP concentration in femtomoles/million cells (fmol/10E6 cells)

    36 weeks

Study Arms (2)

Standard Dose Truvada®

ACTIVE COMPARATOR

Standard Dose Truvada® - Tenofovir disoproxil fumarate (TDF) 300 mg/Emtricitabine (FTC) 200 mg fixed dose combination (Truvada®), one tablet each day

Drug: Standard dose Truvada®

Pregnancy-Adjusted Truvada®

EXPERIMENTAL

Pregnancy-Adjusted dose Truvada® - Tenofovir disoproxil fumarate (TDF) 300 mg/Emtricitabine (FTC) 200 mg fixed dose combination (Truvada®), two tablets each day

Drug: Pregnancy-adjusted dose Truvada®

Interventions

Standard dose Truvada®DRUG

TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, one tablet each day

Also known as: Tenofovir Disoproxil Fumarate/Emtricitabine, TDF/FTC
Standard Dose Truvada®
Pregnancy-adjusted dose Truvada®DRUG

TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, two tablets each day

Also known as: Tenofovir Disoproxil Fumarate/Emtricitabine, TDF/FTC
Pregnancy-Adjusted Truvada®

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust have documented evidence of pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • Able to speak English, French, or Spanish
  • Able and willing to provide written informed consent
  • Viable first (preferable) or second trimester intrauterine pregnancy
  • Creatinine clearance \>70 ml/min
  • Negative HIV test and no signs/symptoms of acute HIV infection,
  • Documented negative hepatitis B virus status.

You may not qualify if:

  • HIV positive at any time in the study. All neonates of mothers participating in the trial will be recruited, regardless of gestational age at delivery or congenital anomalies/comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationTenofovirEmtricitabine

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Craig Hendrix, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The investigators will randomly allocate participants in a 1:1 ratio to two parallel study arms (based on a computer generated randomization scheme).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 8, 2019

Study Start

April 1, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

April 6, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share