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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tablet characteristics that matter to patients for ease of swallow and for adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John E. McKinnon, MD, MSc | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John McKinnon | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19936158 | Background | 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. | |
| 17914895 | 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. |
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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.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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.
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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.
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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 |
| 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 |
| 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 |
| Background | FDA. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance for Industry June 2015 |
| 26543509 | 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. |
| 23924679 | 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. |
| 15763606 | 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. |
| 23052416 | 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. |
| 24678765 | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |