B/F/TAF Ease of Swallowability Trial

Completed · Not applicable · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT04600687

Run by

Henry Ford Health System

People needed

50

Starts

2018-11-06

Expected to finish

2020-10-10

Last updated by the study team

2020-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• John McKinnon — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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