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NCT Number: NCT04600687

B/F/TAF Ease of Swallowability Trial

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John McKinnon

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Placebo tablets

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Acronym: BEST

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2020
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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