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Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834909
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 6, 2019
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date March 20, 2020
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Plasma Tenofovir (TFV) Concentration [ Time Frame: 36 weeks ]
    Plasma Tenofovir (TFV) Concentration in nanograms per milliliter (ng/mL)
  • Plasma Emtricitabine (FTC) Concentration [ Time Frame: 36 weeks ]
    Plasma Emtricitabine (FTC) Concentration in nanograms per milliliter (ng/mL)
  • Peripheral Blood Mononuclear Cell (PBMC) TFV-Diphosphate (TFV-DP)Concentration [ Time Frame: 36 weeks ]
    PBMC TFV-DP concentration in femtomoles/million cells (fmol/10E6 cells)
  • Peripheral Blood Mononuclear Cell (PBMC) FTC-Triphosphate (FTC-TP)Concentration [ Time Frame: 36 weeks ]
    PBMC TFV-DP concentration in femtomoles/million cells (fmol/10E6 cells)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)
Official Title  ICMJE Correcting Pre-Exposure Prophylaxis (PrEP) Dosing and Adherence Benchmarks in Pregnancy to Optimize HIV Prevention (PrEP-P): A Randomized Comparative Pharmacokinetic Trial
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.
Detailed Description

Study participants will be randomized to one of two parallel study arms, involving dosing of tenofovir disoproxil sodium/emtricitabine (TDF/FTC). The investigators will be recruiting and enrolling in the late 1st (preferred) and 2nd trimesters of pregnancy to capture the changes in kidney function and blood flow through the kidneys that appear to start in the late 1st trimester and are most significant in the 2nd and 3rd trimesters of pregnancy. Given the unknown time frame for the return to pre-pregnancy physiologic state and the increased risk of HIV acquisition postpartum, participants will be continued on study dose PrEP until after participants' 1-3 week postpartum visit, after which all participants will be dispensed standard dose PrEP. A 6-12 week postpartum study visit will also be performed to evaluate the timing of return to non-pregnant plasma drug levels during the postpartum period.

PK Sampling. Primary PK data will be derived from up to 7 study visits with PK sampling, including two PK visits in each trimester and postpartum. All PK visits sample blood before an observed PrEP dose. .

Safety Sampling. Maternal safety assessments will continue until 6 months postpartum. Fetal evaluation includes non-invasive limited ultrasound (US) and biophysical profiles (BPP) at study visits and 2nd and 3rd trimester interval growth US, and chart review of all before birth assessments. At birth, the investigators will obtain cord blood plasma to assess for mitochondrial function. Infant safety assessments will continue until 1 year of life. Infants will undergo swaddled Dual-energy X-ray absorptiometry (DXA) scans (without sedation) at 3-6, 24-28, and 50-54 weeks of age. The investigators will assess kidney function by blood sample at 3-6 weeks of life and repeated at 24-28 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The investigators will randomly allocate participants in a 1:1 ratio to two parallel study arms (based on a computer generated randomization scheme).
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pregnancy
  • HIV-1-infection
Intervention  ICMJE
  • Drug: Standard dose Truvada®
    TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, one tablet each day
    Other Names:
    • Tenofovir Disoproxil Fumarate/Emtricitabine
    • TDF/FTC
  • Drug: Pregnancy-adjusted dose Truvada®
    TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, two tablets each day
    Other Names:
    • Tenofovir Disoproxil Fumarate/Emtricitabine
    • TDF/FTC
Study Arms  ICMJE
  • Active Comparator: Standard Dose Truvada®
    Standard Dose Truvada® - Tenofovir disoproxil fumarate (TDF) 300 mg/Emtricitabine (FTC) 200 mg fixed dose combination (Truvada®), one tablet each day
    Intervention: Drug: Standard dose Truvada®
  • Experimental: Pregnancy-Adjusted Truvada®
    Pregnancy-Adjusted dose Truvada® - Tenofovir disoproxil fumarate (TDF) 300 mg/Emtricitabine (FTC) 200 mg fixed dose combination (Truvada®), two tablets each day
    Intervention: Drug: Pregnancy-adjusted dose Truvada®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2027
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Must have documented evidence of pregnancy
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Danielle Signer, BS (443) 287-7156 dsigner1@jhmi.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03834909
Other Study ID Numbers  ICMJE Not Provided
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Craig Hendrix, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP