Comparison of the Ease of Swallowability of B/F/TAF Placebo Compared to DTG/ABC/3TC Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of the ease of swallowability and tolerability of two antiretroviral placebo tablets
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Comparison of the ease of swallowability and tolerability of two antiretroviral placebo tablets
时间窗: One hour
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.
次要结局
- Patient's ease of swallow and medication preferences impact on medication adherence(One hour)
- 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)
- How patient's cultural differences affect acceptability of pill/tablet size(One hour)
研究者
John E. McKinnon, MD, MSc
Senior Staff
Henry Ford Health System