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HIV InfectionsBESTNCT04600687

B/F/TAF Ease of Swallowability Trial

A study of HIV Infections, run by Henry Ford Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
6 Nov 2018to 10 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • John McKinnon

    Detroit, Michigan, 48202

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Placebo tablets
Keywords
HIV, adherence, tolerability
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo tabletsOther

    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.

Study groups in NCT04600687
Study groupRoleWhat they receive
Intervention ArmExperimentalParticipants 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.
Receives: Other: Placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: One hour

Secondary outcomes (4)

  1. 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.

    Measured: One hour

  2. 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.

    Measured: One hour

  3. 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.

    Measured: One hour

  4. 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.

    Measured: One hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start6 Nov 2018
  3. Primary completion8 May 2019
  4. Study completion10 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600687
Sponsor's protocol ID
Gilead Study #CO-US-380-4657
Acronym
BEST
Status last verified
Oct 2020
First submitted
2 Apr 2019
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: After completion of the study and publication of the manuscript(s), the data will be made available for other researchers upon written request and review of the principal investigator.

Publications

  • 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.

    PubMed 19936158

  • 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.

    PubMed 17914895

  • 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.

    PubMed 26543509

  • 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.

    PubMed 23924679

  • 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.

    PubMed 15763606

  • 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.

    PubMed 23052416

  • 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.

    PubMed 24678765

Questions about this trial

What is this clinical trial studying?

A study of HIV Infections, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the ease of swallowability and tolerability of two antiretroviral placebo tablets (time frame: One hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600687, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.

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