B/F/TAF Ease of Swallowability Trial (BEST)

October 18, 2020 updated by: John E. McKinnon, MD, MSc, Henry Ford Health System

Comparison of the Ease of Swallowability of B/F/TAF Placebo Compared to DTG/ABC/3TC Placebo

The trial will assess the tolerability and swallowability of a STR placebo of B/F/TAF as compared to DTG/ABC/3TC placebo STR in healthy individuals and HIV antiretroviral naïve patients. The study team will evaluate the ease of swallow and patient's tolerance of the medication formulation, an important, yet often overlooked aspect of ART adherence, with the potential for significant impact on patient's outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will plan to recruit 50 volunteers who will be randomized to receive Placebo A (B/F/TAF) or Placebo B (DTG/ABC/3TC). Randomization will ensure that the patients will have equal opportunity to try either placebo tablet first to avoid bias. Randomization will be done by an investigator not evaluating or providing the questionnaires to the patient. Participants will complete a questionnaire regarding what medications they take and what factors they consider affect their ease to swallow pills or tablets. The participants will be administered one of the placebo tablet with the research investigator present and will complete a questionnaire immediately following the first placebo dose. A study timeout for 15-30 minutes will be done following completion of the questionnaires. After which, participants will take the second placebo tablet and complete the final questionnaires.

The primary comparison will be between the placebo tablets A and B for tolerability, ease of swallow and participant preference. The investigators estimate that the sample size needed to detect a difference of at least 1 point in a 5 point Likert scale will be 50 patients with a standard deviation of 2 points, with >90% power.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • John McKinnon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. HIV seronegative or seropositive treatment naïve adult over 18 years of age, currently in stable condition, ambulatory and able to swallow tablets or pills.
  2. Patients able to provide informed consent and remain in clinic for at least 2 hours.
  3. Study participants able to complete the study questionnaires.
  4. No known history of allergies to any of the placebo components.

Exclusion Criteria:

  1. Patients with known dysphagia or motility disorders leading to difficulty swallowing liquids, food or medications.
  2. Patients allergic to any component of the placebo tablets.
  3. Children under the age of 18 years.
  4. Adults unable to provide informed consent.
  5. Female patients known to be pregnant.
  6. HIV seropositive patients on antiretroviral therapy or with prior history of antiretroviral therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Arm
Participants will be enrolled in a single arm with a cross over design. Each participant will receive both placebo tablets about 30 minutes apart. Questionnaires will be completed prior to and after each placebo tablet is swallowed.
Other: Placebo tablets
Participants will take placebo tablets identical to the commercial versions of the two combination antiretroviral single tablet regimens of bictegravir/emtricitabine/tenofovir alanfenamide and dolutegravir/abacavir/lamivudine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the ease of swallowability and tolerability of two antiretroviral placebo tablets
Time Frame: One hour
To evaluate the ease and tolerability of swallowing and tolerability of two antiretroviral placebo tablet representing Bictegravir/Emtricitabine/TAF (B/F/TAF) single tablet as compared to a placebo tablet representing Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) by Likert scale questionnaire assessment.
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of pill/tablet size of two antiretroviral placebo tablets on acceptability for patients for adherence.
Time Frame: One hour
To assess whether a smaller pill/tablet size is associated with better acceptance by patients by questionnaire.
One hour
Tablet characteristics that matter to patients for ease of swallow and for adherence
Time Frame: One hour
To determine which particular tablet characteristic is more important as indicated by patients that affects their acceptance of a particular tablet or medication by questionnaire.
One hour
Patient's ease of swallow and medication preferences impact on medication adherence
Time Frame: One hour
To assess patients' view on how pill/tablet size and ease of swallow impacts their medication adherence by questionnaire using a Likert scale.
One hour
How patient's cultural differences affect acceptability of pill/tablet size
Time Frame: One hour
To determine if there are any cultural or ethnic differences in pill/tablet acceptance or ease of swallow.
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: John E. McKinnon, MD, MSc, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2018

Primary Completion (ACTUAL)

May 8, 2019

Study Completion (ACTUAL)

October 10, 2020

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

October 18, 2020

First Posted (ACTUAL)

October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 18, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gilead Study #CO-US-380-4657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After completion of the study and publication of the manuscript(s), the data will be made available for other researchers upon written request and review of the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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