UC Davis Health Clinical Studies

A Study of the Safety and Activity of Experimental GS-6207 Injection for HIV-1 Infected Adults

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The purpose of this study is to test the experimental medicine GS-6207 (referred to as study drug). We hope to determine how it affects the HIV infection in your body and how long the study drug stays in your body. The safety and how well the study drug is tolerated will also be determined by using: - physical exams, - laboratory tests, and - any symptoms or problems you might experience during the study.

Drug study, Phase 1
Any, age 18 to 65 years old

A Study Testing the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy in Cystic Fibrosis

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This study is being done to learn more about the effectiveness and safety of an experimental combination of medicines. The combination of VX-445/tezacaftor (TEZ)/ivacaftor (IVA) will be tested in patients with cystic fibrosis. • The triple combination VX-445/TEZ/IVA is an experimental drug. This means the study drug is not approved by the FDA. It is still being tested for safety and effectiveness. • TEZ in combination with IVA (TEZ/IVA) is approved in certain countries for use in some people living with CF who are 12 years or older. • IVA is approved in a number of countries globally, for use in some people living with CF who are as young as 6 months, depending on the country. If you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved, please ask your Study Doctor.

Drug study, Phase 3
Any, age 12 years or older

A Study of Experimental VX-445 Combination Therapy for Cystic Fibrosis with Genetic Mutations (F508del and Gating or Residual)

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This study will test the effectiveness and safety of the experimental medicine VX-445. It will be combined with TEZ and IVA in subjects with cystic fibrosis (CF). • The triple combination VX-445/TEZ/IVA is an experimental drug. This means the Study Drug is not approved by the FDA and is still being tested for safety and effectiveness. • TEZ combined with IVA (TEZ/IVA) is approved in some countries for use in some people living with CF who are 12 years or older. • IVA, the third Study Drug used in this study, is approved in a number of countries globally. It is used for people living with CF who are as young as 6 months, depending on the country. • Please ask the Study Doctor if you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved.

Drug study, Phase 3
Any, age 12 years or older

Study of Experimental Sulbactam-ETX2514 Infections Caused by Acinetobacter baumannii-calcoaceticus Complex

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We are doing this study to test the effectiveness and safety of the experimental drug sulbactam-ETX2514. It is being tested for the treatment of infections caused by A. baumannii bacteria. This type of infection is usually resistant to many existing drugs. New drugs are needed to effectively fight A. baumannii bacteria. The study drug is not approved for the treatment of infections due to A. baumannii. The study drug itself is made up of two chemicals, one is called ETX2514, an investigational antibiotic. The other chemical that makes up the study drug is called sulbactam, an FDA-approved antibiotic. The combination that is this study drug is called “ETX2514SUL.”

Drug study, Phase 3
Any, age 18 years or older

A Study of Experimental Therapy With Nivolumab For Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

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This study is being done to answer the following question: Can we safely and effectively treat your cancer with nivolumab given any of the following auto-immune diseases? -Rheumatoid arthritis -Polymyalgia rheumatica -Sjogrens -Ulcerative colitis -Crohn's disease -Systemic lupus erythroderma -Dermatomyositis -Multiple sclerosis Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your cancer and your auto-immune disease. The usual approach is defined as care most people get for their cancer while having an auto-immune disease. Treatment with nivolumab is considered experimental. It is not currently approved by the FDA for cancer in people with auto-immune diseases.

Drug study, Phase 1
Any, age 18 years or older

A Study of the Safety and Effectiveness of Experimental Lonafarnib / Ritonavir for Chronic Hepatitis D Virus Infection

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This study is for patients with chronic (long-lasting) hepatitis D virus (HDV) infection. Potential participants must be taking or be willing to begin taking nucleotide/nucleoside inhibitors (entecavir or tenofovir). These nucleotide/nucleoside inhibitors must be taken for at least 12 weeks to 6 months before beginning the study treatment. The purpose of this study is to determine whether the study drugs will reduce the amount of HDV in your blood. Other purposes of this study are: - to determine the effects of the study drugs on your liver - to determine if taking the study drugs makes your quality of life better - to evaluate the safety of the study drugs The Sponsor is conducting this study to find new treatments for HDV. This research study is designed to learn more about an investigational drug called lonafarnib. It is being developed to treat chronic HDV infection as well as other conditions. "Investigational" means lonafarnib is not yet approved by the FDA for prescription or over the-counter (OTC) use. Lonafarnib will be taken in combination with an approved drug called ritonavir. Ritonavir is commonly used in the treatment of hepatitis C at comparable dosing to what will be used in this study. In this study, ritonavir is used as a “booster” to increase the amount of lonafarnib in your body. A “booster” is a drug that prevents your body from breaking down lonafarnib, so it can work longer. Some patients in this study will take an interferon medicine approved for treating HBV and hepatitis C virus (HCV) infections. This medicine is called peginterferon-alfa-2a (abbreviated as PEG IFN-alfa-2a). PEG IFN-alfa-2a will be a potential added medicine in this study. We hope to determine if it improves the treatment outcome when taken with lonafarnib and ritonavir. Peginterferon-alfa-2a is a solution that is injected under the skin once per week.

Drug study, Phase 3
Any, age 18 years or older

A Study of the Experimental Medicine SUBA-itraconazole Compared to Standard Treatment for Endemic Mycoses (fungal infection)

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Treatment of fungal infections can be difficult. The majority require long courses of anti-fungal treatment, often requiring long-term therapy. This study will determine how safe, effective and well-tolerated an experimental fungal drug, SUBA-itraconazole, is. It will be compared to standard treatment with the drug itraconazole. Standard treatment is the medication normally given to patients with fungal infection. There are 2 arms (treatment groups) in this research study, ARM A and ARM B. You will be randomized by chance (1:1) to one of the two arms. You have an equal chance to be assigned to either arm. • ARM A: Open-label study drug treatment by mouth 2 capsules, with food, three times a day for 3 days, then two times a day until day 180 ARM B: Open-label conventional treatment (non-study drug) by mouth 2 capsules, with food, three time a day for 3 days, then two times a day until day 180

Drug study, Phase [/2/,/ /3/]
Any, age 19 years or older

A Study of Experimental Fenretinide (LAU-7b) for Cystic Fibrosis in Adults

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Cystic fibrosis (CF) is a multi-system disease affecting the respiratory tract. It involves the lungs, nose, and sinuses, pancreas, liver, sweat glands, and reproductive organs. The lungs often experience ongoing infection (usually with bacteria called Pseudomonas aeruginosa). It sustains out-of-control inflammation that results in irreversible damage. This is a research study of an experimental drug called fenretinide (LAU-7b). Experimental means that this drug has not been approved by the U.S. Food and Drug Administration (FDA). The study drug (LAU-7b) is a derivative of Vitamin A. The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function. We hope it will reduce the persistent inflammation in the lung. We also hope it improves the lung's capacity to defend against bacteria such as Pseudomonas aeruginosa. The main goals of this study are to determine if fenretinide: Is safe and well tolerated Improves lung function as measured by spirometry. Spirometry is a routinely performed test to measure lung function.

Drug study, Phase 2
Any, age 18 years or older

Primary Biliary Cholangitis with incomplete response or intolerant to ursodeoxycholic acid? Participate in a clinical trial

Help us evaluate if a new investigational drug is safe and effective in the treatment of PBC

We invite you to take part in a research study because you have primary biliary cholangitis (PBC) and you are not responding well enough to or can't tolerate ursodeoxycholic acid. You must have been taking a stable dose of ursodeoxycholic acid (UDCA) for the past twelve months, OR you're not able to tolerate UDCA due to side effects. This study will test the safety and efficacy of an investigational medicine called seladelpar. Previous research has shown that seladelpar may help treating the signs and symptoms of PBC, lower your alkaline phosphatase level, and decrease itching. Primary Biliary Cholangitis (PBC) is a autoimmune chronic liver disease that destroys the bile ducts within the liver. You will receive all study medication and study evaluations at no cost, and compensation for your time may be available.

Drug study, Phase 3
Any, age 18 to 75 years old
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