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Tenofovir Adherence to Rapidly Guide and Evaluate PrEP and HIV Therapy (TARGET)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by University of Washington
Sponsor:
Collaborators:
Chiang Mai University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Paul Drain, University of Washington
ClinicalTrials.gov Identifier:
NCT03012607
First received: January 4, 2017
Last updated: January 6, 2017
Last verified: January 2017
  Purpose

Adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are critical to the success of HIV treatment and therapeutic prevention. No accurate, objective point-of-care test is available to monitor adherence to either ART or PrEP. The inability to accurately identify poorly adherent patients will lead to more HIV infections (from failed PrEP and non-suppressive ART), more drug-resistant virus (selected by failing ART), and unnecessary switching to costly second- or third-line ART (when first-line regimens with virologic efficacy but non-adherence are stopped inappropriately). To address this critical knowledge gap, the investigators have developed a novel point-of-care test to detect the presence of tenofovir—the most common drug in both ART and PrEP treatments worldwide—in fingerprick blood or urine as an objective measure of ART and PrEP adherence.

Our central hypothesis is that the pharmacokinetics of tenofovir in blood and urine will support point-of-care tenofovir detection as an objective measure of adherence, and that our point-of-care tenofovir assay will have the ability to discriminate different drug adherence levels. The investigators will test our central hypotheses by pursuing the following two specific aims: (1) To assess our novel point-of-care tenofovir (TFV) assay in whole blood and urine specimens within a controlled pharmacokinetic study of HIV-negative adults receiving tenofovir disoproxil fumarate (TDF) with low, moderate, and perfect adherence; and (2) To validate our novel point-of-care tenofovir (TFV) assay on blood and urine specimens using an existing biorepository from a real-world clinical HIV prevention study.

This work is innovative because it develops an entirely new category of rapid diagnostic testing for monitoring ART and PrEP adherence at the clinical point of care. Our rapid assay will help clinicians identify patients in need of more adherence counseling, which when implemented will prevent HIV acquisition, emergence of drug resistant virus, and unnecessary ART regimen switching—measures that will improve national HIV programs and help preserve the global supply of an effective HIV medication.


Condition Intervention
Hiv
Drug: Truvada

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pharmacokinetics of Tenofovir in Blood, Plasma and Urine of Healthy Adults With Perfect, Median and Low Drug Adherence

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of Truvada concentration [ Time Frame: 24, 48, 72 hours post-dose ]

Secondary Outcome Measures:
  • Maximum plasma concentration of Truvada [ Time Frame: 24, 48, 72 hours post-dose ]
  • Renal clearance of Truvada [ Time Frame: 24, 48, 72 hours post-dose ]
  • Time to Maximum Plasma Concentration(Cmax) of Truvada [ Time Frame: 24, 48, 72 hours post-dose ]

Estimated Enrollment: 30
Study Start Date: January 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perfect Adherence
Participants will receive a single tablet of TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA] once daily for 6 weeks
Drug: Truvada
Participants will be randomized into 1 of 3 groups (10 participants/group) to receive a controlled number of doses of tenofovir disoproxil fumarate (TDF, 300mg) in a combination pill with emtricitabine (FTC, 200mg) (Truvada®)
Experimental: Moderate Adherence
Participants will receive a single tablet of TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA] 4 times per week (Monday, Wednesday, Friday, and Saturday) for 6 weeks
Drug: Truvada
Participants will be randomized into 1 of 3 groups (10 participants/group) to receive a controlled number of doses of tenofovir disoproxil fumarate (TDF, 300mg) in a combination pill with emtricitabine (FTC, 200mg) (Truvada®)
Experimental: Poor Adherence
Participants will receive a single tablet of TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA] 2 times per week (Monday, Thursday) for 6 weeks
Drug: Truvada
Participants will be randomized into 1 of 3 groups (10 participants/group) to receive a controlled number of doses of tenofovir disoproxil fumarate (TDF, 300mg) in a combination pill with emtricitabine (FTC, 200mg) (Truvada®)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 and <50 years old
  • HIV and Hepatitis B surface Ag negative
  • Normal renal function (estimated GFR >60 mL/min by the Cockcroft-Gault equation)
  • Willing/able to provided written informed consent

Exclusion Criteria:

  • Pregnant female
  • Any significant lab abnormality of neutrophil count, hemoglobin, platelets, AST, or ALT (Defined as Grade ≥3 by DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, Nov. 2014)
  • History of using PrEP or thought to be eligible to receive PrEP.
  • Any clinically significant diseases or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, might compromise participation in this study
  • Any concurrent participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03012607

Contacts
Contact: Tim R Cressey, PhD 053 894-994 tim.cressey@phpt.org
Contact: Virat Klinbuayaem, MD 053 311 404 kggvirat@hotmail.com

Sponsors and Collaborators
University of Washington
Chiang Mai University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Paul Drain, MD, MPH University of Washington
Principal Investigator: Tim R Cressey, PhD Chiang Mai University
Principal Investigator: Oraphan Siriprakaisil, MD Sanpatong Hospital, Chiang Mai
Principal Investigator: Virat Klinbuayaem, MD Sanpatong Hospital, Chiang Mai
  More Information

Responsible Party: Paul Drain, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03012607     History of Changes
Other Study ID Numbers: STUDY00000058  R21AI127200-01 
Study First Received: January 4, 2017
Last Updated: January 6, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: We will make decisions to share IPD on case by case basis

Keywords provided by University of Washington:
PrEP

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 24, 2017