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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 : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Pregnancy HIV-1-infection Drug: Standard dose Truvada® Drug: Pregnancy-adjusted dose Truvada® Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Correcting Pre-Exposure Prophylaxis (PrEP) Dosing and Adherence Benchmarks in Pregnancy to Optimize HIV Prevention (PrEP-P): A Randomized Comparative Pharmacokinetic Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. Plasma Tenofovir (TFV) Concentration [ Time Frame: 36 weeks ]
    Plasma Tenofovir (TFV) Concentration in nanograms per milliliter (ng/mL)

  2. Plasma Emtricitabine (FTC) Concentration [ Time Frame: 36 weeks ]
    Plasma Emtricitabine (FTC) Concentration in nanograms per milliliter (ng/mL)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must have documented evidence of pregnancy
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834909


Contacts
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Contact: Danielle Signer, BS (443) 287-7156 dsigner1@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Craig Hendrix, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03834909    
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
HIV Prevention
Healthy Volunteer
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents