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

Henry Ford Health

Status: Completed

Conditions: HIV Infections

Treatments: Other: Placebo tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04600687

Gilead Study #CO-US-380-4657

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention Arm

Experimental group

Description:

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.

Treatment:

Other: Placebo tablets