B/F/TAF Ease of Swallowability Trial

HIV Infections Clinical Trial

— BEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600687
• Other study ID #: Gilead Study #CO-US-380-4657
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: October 2020
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 10, 2020
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	John McKinnon	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bhosle M, Benner JS, Dekoven M, Shelton J. Difficult to swallow: patient preferences for alternative valproate pharmaceutical formulations. Patient Prefer Adherence. 2009 Nov 3;3:161-71. — View Citation

de Argila CM, Ponce J, Márquez E, Plazas MJ, Galván J, Heras J, Porcel J. Acceptability of lansoprazole orally disintegrating tablets in patients with gastro-oesophageal reflux disease : ACEPTO study. Clin Drug Investig. 2007;27(11):765-70. — View Citation

FDA. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance for Industry June 2015

Fields J, Go JT, Schulze KS. Pill Properties that Cause Dysphagia and Treatment Failure. Curr Ther Res Clin Exp. 2015 Aug 20;77:79-82. doi: 10.1016/j.curtheres.2015.08.002. eCollection 2015 Dec. — View Citation

Kakuda TN, Berckmans C, De Smedt G, Leemans R, Leopold L, Peeters M, Nijs S, Vyncke V, van Solingen-Ristea R, Hoetelmans RM. Single-dose pharmacokinetics of pediatric and adult formulations of etravirine and swallowability of the 200-mg tablet: results from three Phase 1 studies. Int J Clin Pharmacol Ther. 2013 Sep;51(9):725-37. doi: 10.5414/CP201770. — View Citation

Nausieda PA, Pfeiffer RF, Tagliati M, Kastenholz KV, DeRoche C, Slevin JT. A multicenter, open-label, sequential study comparing preferences for carbidopa-levodopa orally disintegrating tablets and conventional tablets in subjects with Parkinson's disease. Clin Ther. 2005 Jan;27(1):58-63. Erratum in: Clin Ther. 2005 Mar;27(3):360. — View Citation

Schiele JT, Quinzler R, Klimm HD, Pruszydlo MG, Haefeli WE. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013 Apr;69(4):937-48. doi: 10.1007/s00228-012-1417-0. Epub 2012 Sep 29. — View Citation

Singh JA. Facilitators and barriers to adherence to urate-lowering therapy in African-Americans with gout: a qualitative study. Arthritis Res Ther. 2014 Mar 29;16(2):R82. doi: 10.1186/ar4524. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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