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Single Dose Truvada Study

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03719053
Collaborator
(none)
44
Enrollment
1
Location
1
Arm
20.2
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
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 :
Oct 25, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

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 Names:
  • Truvada

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma Tenofovir (TFV) concentration in ng/mL [24 hours]

    2. Peripheral Blood Mononuclear Cells (PBMC) TFV diphosphate (TFV-DP) concentration in femtomole per million cells (fmol/10^6) [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hospital Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Craig Hendrix, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT03719053
    Other Study ID Numbers:
    • IRB00174702
    First Posted:
    Oct 25, 2018
    Last Update Posted:
    Jul 16, 2020
    Last Verified:
    Jul 1, 2020
    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:
    Tenofovir

    Study Results

    No Results Posted as of Jul 16, 2020