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B/F/TAF Ease of Swallowability Trial

NCT ID: NCT04600687

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2020-10-10

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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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Intervention Arm

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.

Group Type EXPERIMENTAL

Placebo tablets

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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John E. McKinnon, MD, MSc

Senior Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John E. McKinnon, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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John McKinnon

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19936158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17914895 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 26543509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23924679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15763606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23052416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24678765 (View on PubMed)

Other Identifiers

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Gilead Study #CO-US-380-4657

Identifier Type: -

Identifier Source: org_study_id