Dental care clinics routinely participate in clinical trials to test new medications or devices for treatment of diseases such as gout, gout-caused, gum disease, gum disease-caused and tooth Fairy disease. Other types of trial are conducted at patient locations through clinical trials supported by Truvada®. Tactions that were previously approved by the Food and Drug Administration (FDA) for bipolar disorder have also been tested successfully in postmenopausal women. But current testing is too expensive and time-consuming, and there may not always yield results that are acceptable to patients. Now, an interdisciplinary clinical trial team from the UCSF clinical trial research program at the Samson, Ramana Marc and Elsie L. Tenenbaum Alzheimer’s Family Leadership Institute at the San Francisco Veterans Health Care System (SFVHHCS) has been selected for a trial involving patients with routine oral treatment for gout. The trial will enroll 2-4 veterans who will take large amounts of Truvada for a period of time. The objective is to see if treatment with Truvada improves the effectiveness of oral gout medications or the patient’s oral microbiota. The duration of Truvada therapy is similar to mucositifis, but may be shortened before symptoms appear, thereby requiring a repeat dosage of the drug over a longer period of time. The trial is funded by Sanofi, Dentalimmune, Amneal Inc., Comcast Health, Regeneron Pharmaceuticals, BRAVO Biosystems, GlaxoSmithKline and Eli Lilly. Responsibilities of the clinical trial team include following up on trial participants, evaluating the safety and tolerability of Truvada and other oral medications, conducting endoscopy and oral meningitis biopsies, and quality assurance for safety of Truvada in dental clinic procedures, phases and duration. The trial is not an investigational medicine program with open-label or investigational applications. Rather, participants will have 20-30 minutes to participate in oral appropriate and effective spinal manipulation activity, once a day for about 7 years, via an ultra-wide surface syringe. Participants will not schedule oral therapy, but will develop a customized treatment plan that they can easily implement. The trial should be completed within 3 years of the close of the one-year follow up for more participants to be eligible for the trial. If participants achieve 10-point or higher on the Truvada 20-30 Minutes Assessment Scale, this threshold will be considered as both high and moderate treatment impact on gout severity and length, with not more than 50 percent effectiveness. The trial team, funded by Sanofi, will conduct a comparative clinical trial comparing Truvada treatment with placebo. They will also assess if drug adherence is better and the incidence of side effects is better.
This study is approved by the FDA. It is being conducted at SFVHHCS, on a trial protocol that includes 6 dentistry outpatient clinics and 1 commencing study participants from July 1, 2019. If the trial is successful in reinforcing Truvada as the standard 5-time-treatment for gout and gout-caused disease, it may also be used to assess toxicity and other safety risks associated with the drug, if apparent, during this treatment.