B/F/TAF Ease of Swallowability Trial

NCT04600687 | Completed

• 1 other identifier: Gilead Study #CO-US-380-4657
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

HIV; adherence; tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Impact of pill/tablet size of two antiretroviral placebo tablets on acceptability for patients for adherence.

  One hour

• Tablet characteristics that matter to patients for ease of swallow and for adherence

  One hour

• Patient's ease of swallow and medication preferences impact on medication adherence

  One hour

• How patient's cultural differences affect acceptability of pill/tablet size

  One hour

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

John McKinnon

Detroit, Michigan, 48202, United States

Location

Related 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. doi: 10.2147/ppa.s5691.

  PMID: 19936158 BACKGROUND

• de Argila CM, Ponce J, Marquez E, Plazas MJ, Galvan 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. doi: 10.2165/00044011-200727110-00003.

  PMID: 17914895 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26543509 BACKGROUND

• 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.

  PMID: 23924679 BACKGROUND

• 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. doi: 10.1016/j.clinthera.2005.01.004.

  PMID: 15763606 BACKGROUND

• 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.

  PMID: 23052416 BACKGROUND

• 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.

  PMID: 24678765 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• John E. McKinnon, MD, MSc

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Neither the participant nor the person administering the questionnaires will know which placebo tablet the patient has been randomized to receiving first prior to study enrollment. The allocation of which placebo tablet is first swallowed will be randomized in a block randomization design.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: October 23, 2020
• Study Start: November 6, 2018
• Primary Completion: May 8, 2019
• Study Completion: October 10, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

US (1)