B/F/TAF Ease of Swallowability Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Placebo tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be randomized to take the first placebo tablet and within 30 minutes then take the second placebo tablet. The participants will complete questionnaires prior to taking any placebo pill and after each dose.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the ease of swallowability and tolerability of two antiretroviral placebo tablets | 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. | 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 | 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 | 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 | To determine if there are any cultural or ethnic differences in pill/tablet acceptance or ease of swallow. | One hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, adherence, tolerability