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ENLIGHTEN: Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03218592
First received: July 10, 2017
Last updated: July 12, 2017
Last verified: July 2017
  Purpose

Purpose: Perform a 3-phase (single dose, multi dose, dose proportionality) study in healthy volunteers using daily tenofovir+emtricitabine, dolutegravir, and maraviroc dosing to quantify intra- and inter-subject variability and dose proportionality. The influence of covariates on ARV hair distribution (e.g., hair growth rate, race, hair color, hair treatment) will also be measured. Using both population PK modeling and physiologic based PK (PBPK) approaches, a statistical model to quantify ARV adherence patterns based on signal intensity/pattern will be developed.

Participants: Healthy volunteers, aged 18 to 70 years of age, inclusive on the date of screening, with an intact gastrointestinal system and at least 1cm caput hair.

Procedures (methods): Participants will be sequentially assigned to enroll in a dosing arm, beginning with maraviroc, then dolutegravir, and ending with tenofovir/emtricitabine. All participants will take a single observed dose of study product in Phase 1, with blood and hair samples obtained on Days 3, 7, 14, 21 and 28 days post-dose. In Phase 2, all participants take 28 days straight of daily dosing, observed, of the same study product. Blood and hair samples obtained on the same days post-dose. In Phase 3, participants will be randomized to stop their drug, or decrease dosing to one or three doses weekly. Hair and blood samples will again be obtained on the same days post-dose. All participants will complete a follow-up safety visit with 14 days of completing study sampling.


Condition Intervention Phase
HIV/AIDS Drug: Maraviroc Pill Drug: Dolutegravir Pill Drug: Truvada Pill Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Observational, Prospective. Single-center, open-label, 3-arm, triple stage study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ENLIGHTEN: Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Hair Antiretroviral concentrations [ Time Frame: Up to 28 days post dose ]
    Concentrations will be measured in hair of all study drugs, inclusive of FTC, TFV, MRV, and DTG


Secondary Outcome Measures:
  • PBMC Antiretroviral Concentrations [ Time Frame: Days 3, 7, 14, 21, and 28 post-dose ]
    Concentrations of FTC-TP, TFV-DP will be measured in peripheral blood mononuclear cells in the Truvada arm only

  • Plasma Antiretroviral Concentrations [ Time Frame: Days 3, 7, 14, 21 and 28 days post-dose ]
    Concentrations will be measured in hair of all study drugs, inclusive of FTC, TFV, MRV, and DTG

  • Whole Blood Antiretroviral Concentrations [ Time Frame: Days 3, 7, 14, 21, and 28 days post-dose ]
    Concentrations will be measured in hair of all study drugs, inclusive of FTC, TFV, MRV, and DTG


Estimated Enrollment: 36
Actual Study Start Date: June 28, 2017
Estimated Study Completion Date: March 30, 2019
Estimated Primary Completion Date: December 25, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc
12 Healthy subjects will dose with Maraviroc Pill and we will collect blood and hair over all three phases
Drug: Maraviroc Pill
Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly
Other Name: selzentry
Experimental: Dolutegravir
12 Healthy volunteers will dose with Dolutegravir Pill and we will collect blood and hair over all three phases
Drug: Dolutegravir Pill
Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly
Other Name: Tivicay
Experimental: Truvada
12 healthy volunteers will dose with Truvada Pill and we will collect blood and hair over all three phases
Drug: Truvada Pill
Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly
Other Name: Tenofovir/Emtricitabine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy volunteer between the ages of 18 and 70, inclusive on the date of screening, with an intact gastrointestinal tract. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests
  • Recent medical history in good medical standing, without evidence of fever five days prior to enrollment
  • HIV-negative
  • Able to swallow pills
  • Has minimum hair required to provide study samples
  • Not allergic to any component of the study drug
  • Signed and dated informed consent indicating that they have been informed of all pertinent details of the trial and are willing to participate
  • Willing and able to comply with scheduled visits, laboratory tests and trial procedures
  • Willing to use at least one form of acceptable birth control throughout the duration of the study
  • Negative, or receiving treatment, for syphilis at screening
  • Hemoglobin Grade 2 or lower, with no clinically significant medical issues that would preclude blood sampling

Exclusion Criteria

  • Age outside of desired range
  • Confirmed positive results for HIV, Hepatitis B or C at screening
  • Subjects of all genders actively involved in the conception process, in addition to cisgender female subjects who are in the immediate post-partum period or breastfeeding
  • Insufficient amount of hair or unwilling to keep hair length at least 1 centimeter throughout duration of study
  • Unable or unwilling to comply with all lifestyle measures and/or visits
  • Impaired renal function, as documented by a creatinine clearance <80 mL/min with the Cockcroft-Gault equation
  • Has donated blood within the past 56 days in the amount greater than 500 mL
  • Has taken an investigational drug in the past 4 months
  • Clinical, laboratory, or surgical abnormalities that would preclude sample collection
  • Has a condition, which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately
  • Any clinically significant laboratory result Grade 2 or greater according to the DAIDS Laboratory Grading Tables
  • History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week
  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: NCT03218592

Contacts
Contact: Heather M Asher Prince, PA-C DFAAPA 9199625344 princeH@med.unc.edu
Contact: Angela DM Kashuba, PharmD 9199669998 akashuba@unc.edu

Locations
United States, North Carolina
Clinical and Translational Research Center, UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Heather M Asher Prince, PA-C, DFAAPA    919-962-5344    princeH@med.unc.edu   
Principal Investigator: Angela DM Kashuba, PharmD         
Sub-Investigator: Eli Rosen, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Angela DM Kashuba, BScPhmPharmD University of North Carolina, Chapel Hill
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03218592     History of Changes
Other Study ID Numbers: 17-0546
1R01AI122319-01 ( U.S. NIH Grant/Contract )
Study First Received: July 10, 2017
Last Updated: July 12, 2017

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

Keywords provided by University of North Carolina, Chapel Hill:
Adherence
Hair

Additional relevant MeSH terms:
Emtricitabine
Maraviroc
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Dolutegravir
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
CCR5 Receptor Antagonists
HIV Integrase Inhibitors
Integrase Inhibitors

ClinicalTrials.gov processed this record on September 25, 2017