HIV Infections
Conditions
Keywords
HIV, adherence, tolerability
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.
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.
Interventions
OTHERPlacebo 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.
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the ease of swallowability and tolerability of two antiretroviral placebo tablets | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of pill/tablet size of two antiretroviral placebo tablets on acceptability for patients for adherence. | One hour | To assess whether a smaller pill/tablet size is associated with better acceptance by patients by questionnaire. |
| Tablet characteristics that matter to patients for ease of swallow and for adherence | One hour | 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. |
| Patient's ease of swallow and medication preferences impact on medication adherence | One hour | To assess patients' view on how pill/tablet size and ease of swallow impacts their medication adherence by questionnaire using a Likert scale. |
| How patient's cultural differences affect acceptability of pill/tablet size | One hour | To determine if there are any cultural or ethnic differences in pill/tablet acceptance or ease of swallow. |
Countries
United States
Outcome results
None listed