NCT04600687

B/F/TAF Ease of Swallowability Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-06
• Primary completion: 2019-05-08
• Completion: 2020-10-10
• First posted: 2020-10-23
• Last updated: 2020-10-23

Locations

1 site across 1 country: United States