ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence
Status:
Completed
Trial end date:
2018-12-07
Target enrollment:
Participant gender:
Summary
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 (MVC), then dolutegravir (DTG), and ending with
tenofovir/emtricitabine (TFV/FTC). 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Dolutegravir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Maraviroc Tenofovir