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Single Dose Truvada Study

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ClinicalTrials.gov Identifier: NCT03719053
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study examines tenofovir (TFV) drug concentrations in adults one day after taking a single dose of Truvada® - a pill used to prevent and treat HIV infection. The results of this study will be used to improve the (efficacy/accuracy) of a white coat adherence (WCA) detection test - a blood test that can be used to indicate medication adherence. Participants will receive one dose of Truvada®, and provide 2 total samples of blood.

Condition or disease Intervention/treatment Phase
Medication Adherence HIV Prevention Drug: Tenofovir Phase 1

Detailed Description:

To establish the plasma and peripheral blood mononuclear cells (PBMC) concentrations of TFV and TFV diphosphate (TFV-DP), respectively, following a single oral dose of Truvada® [300 mg tenofovir disoproxil fumarate (TDF) in fixed dose combination with emtricitabine (FTC)], the same formulation used for HIV pre-exposure prophylaxis (PrEP), and in prior benchmarking adherence studies (HPTN 066). This will be compared to steady-state TFV and TFV-DP concentrations to more robustly differentiate single dose concentrations from steady-state concentrations.

This is part of a larger project to determine the frequency of white coat adherence in several clinical studies where doses are not observed. For purposes of diagnosing WCA with TDF, the investigators define WCA quantitatively as taking a single dose of TDF preceded by no doses in the prior week. The investigators will compare TFV and TFV-DP concentrations following an observed single oral dose of TDF/FTC to steady-state concentrations of TFV and TFV-DP after daily dosing under observation.

The study plan involves a screening visit to assess eligibility, followed by two study visits. Visit one involves pre-dose blood testing, followed by a single dose of Truvada. Visit two occurs 24-hours after visit one, and involves collection of a final post-dose blood sample. Blood will be assessed for tenofovir and tenofovir analyte concentrations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Single Observed Dose Administration of Truvada® to Establish Single Dose Pharmacokinetic Standards in Healthy Individuals
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Truvada
single oral dose of Truvada® (300 mg tenofovir disoproxil fumarate)
Drug: Tenofovir
pre- and post-dosing measurements of TFV and TFV-DP in plasma and PBMCs.
Other Name: Truvada




Primary Outcome Measures :
  1. Plasma Tenofovir (TFV) concentration in ng/mL [ Time Frame: 24 hours ]
  2. Peripheral Blood Mononuclear Cells (PBMC) TFV diphosphate (TFV-DP) concentration in femtomole per million cells (fmol/10^6) [ Time Frame: 24 hours ]


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:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy with no acute medical illness
  • Willing to provide written informed consent
  • Age 18 years of age or older
  • Negative qualitative urine pregnancy test at screening and on day of dosing, prior to dosing, female participants only
  • HIV-1 negative at screening, as documented by Combo Ag/Ab HIV-1/HIV-2 immunoassay
  • At screening, no evidence of hepatic or renal impairment [creatinine clearance > 60 ml/min, total bilirubin ≤ upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5 ULN]

Exclusion Criteria:

  • Concomitant antiretroviral or other medication use, for which there is a known risk of pharmacokinetic or pharmacodynamic drug interactions.
  • Active medical or psychological condition that, in the opinion of the investigator, might put the volunteer at undue risk or interfere with the participation of the study.

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): NCT03719053


Contacts
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Contact: Danielle Signer 443 287 7156 dsigner1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Danielle Signer       dsigner1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Craig Hendrix Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03719053    
Other Study ID Numbers: IRB00174702
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tenofovir
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