We are actively recruiting patients for several clinical trials. Learn more about each trial below, including additional details from ClinicalTrials.gov.

Anal Cancer Prevention in HIV Patients

Anal cancer is caused by Human Papillomavirus (HPV), which can cause changes to the skin around and inside the anus. These changes are called high-grade squamous intraepithelial lesions (HSIL). About half of HIV+ MSM have anal HSIL. Not all anal HSIL will develop into cancer. Most HSIL will go away on their own, but some become cancer over time and can eventually spread to other parts of the body.

Dr. Juan de la Ossa is conducting a multi-center study to determine whether screening and treatment of anal HSIL are effective strategies in preventing anal cancer in HIV+ men and women. Participants come in for a screening visit where they undergo a procedure called High Resolution Anoscopy (HRA). HRA allows for examination of the anal canal. Biopsies are obtained during the HRA of anything that is suspicious for HSIL. Participants found to have HSIL are enrolled in the study and assigned into one of two groups. A group where HSIL is treated or a group where HSIL is monitored closely every six months.

To be eligible, participants must be 35 years of age or older and HIV+. Additionally, the screening HRA must show biopsy-proven anal HSIL. Learn more at ClinicalTrials.gov.

Principal Investigator: Juan de la Ossa, MD
Study Coordinator: Gary Brown, CMA

Ankylosing Spondylitis

Dr. Anthony Krajcer is conducting a multi-center study comparing secukinumab 300mg to 150mg in patients with active Ankylosing Spondylitis. Secukinumab (Cosentyx®) is FDA approved for the treatment of active Ankylosing Spondylitis. The use of the 300mg dose is investigational. Ankylosing Spondylitis is a form of arthritis that primarily affects the spine, although other joints can become involved. It causes inflammation of the spinal joints (vertebrae) that can lead to severe, chronic pain and discomfort.

To be eligible, participants must be 18 years of age or older and have moderate to severe Ankylosing Spondylitis despite current or previous treatments. Learn more at ClinicalTrials.gov.

Principal Investigator: Dr. Anthony Krajcer
Sub-Investigator: Jane Park, MD
Study Coordinator: Nicole Davis-Ducksworth, CMA

C diff Infection (Recurrent)

Dr. Trong Tony Trinh is conducting a multi-center study evaluating an investigational drug for the treatment of recurrent C diff infection (CDI). CDI is a bacterial infection of the gut (intestines) that causes severe diarrhea. In the United States CDI affects more than 500,000 annually. Approximately 20 to 30 percent of CDI patients who are treated with commonly used antibiotics experience a recurrence. The risk of recurrence increases with each relapse or reinfection. Currently the approved treatments for recurrent CDI are more antibiotics or surgery, both of which have limitations.

To be eligible, participants must be 18 years of age or older and have recurrent CDI that includes at least two episodes of CDI associated diarrhea controlled only while taking antibiotics. Learn more at ClinicalTrials.gov.

Principal Investigator: Tony Trinh, MD
Study Coordinator: Gary Brown, CMA

Celiac Disease

Dr. Craig Pepin is conducting a multi-center study evaluating an investigational drug for the treatment of abdominal symptoms in patients with Celiac Disease. Celiac Disease is an autoimmune disorder that can occur in genetically predisposed people where the ingestion of gluten leads to damage in the small intestine. Currently the only treatment for Celiac Disease is lifelong adherence to a strict gluten-free diet.

To be eligible, participants must be 18 years of age or older and have Celiac Disease with abdominal symptoms over the past month despite attempting to follow a gluten-free diet for the past 12 months. Learn more at ClinicalTrials.gov.

Principal Investigator: Craig Pepin, MD
Sub-Investigator: Peggy Headstrom, MD
Study Coordinator: Gary Brown, CMA

IgA Nephropathy

Dr. Rex Ochi is conducting a multi-center study evaluating an investigational drug for the treatment of IgA Nephropathy (IgAN). IgAN occurs when a protein called Immunoglobulin A (IgA) gets stuck in the kidneys. This then causes an inflammation of the kidney’s filtering units, called glomeruli. When glomeruli become inflamed, they begin to lose their function, and important proteins start leaking into the urine (proteinuria). The goal in treating IgAN is to stop or lower the amount of protein lost in the urine. Currently there is no approved therapy for IgAN, although treatment can slow the decline of kidney function.

To be eligible, participants must be 18 years of age or older and have IgA Nephropathy. Learn more at ClinicalTrials.gov.

Principal Investigator: Rex Ochi, MD
Sub-Investigators: Lisa Nakamoto, MD and Anne Pesenson, MD
Study Coordinator: Gary Brown, CMA

Migraine (Episodic)

Dr. Braden Nago is conducting a multi-center study evaluating an investigational drug for the prevention of migraine in patients with Episodic Migraine. Migraine is typically characterized by attacks of throbbing, unilateral headache of moderate or severe pain intensity. Episodic Migraine is a diagnosis applied to patients with migraine who have 1-14 headache days per month.

To be eligible, participants must be between 18 and 80 years of age and have at least a 1-year history of Episodic Migraine. Age at the time of migraine onset must be at least 50 years.

Principal Investigator: Braden Nago, MD
Sub-Investigator: Meghana Doreswamy, MD
Study Coordinator: Gary Brown, CMA

Primary FSGS

Dr. Anne Pesenson is conducting a multi-center study evaluating an investigational drug for the treatment Primary Focal Segmental Glomerulosclerosis (FSGS). FSGS is a rare disease that attacks the kidney’s filtering units, called glomeruli, causing serious damage or scarring. When glomeruli become damaged or scarred, proteins begin leaking into the urine. Over the course of many years, the kidneys can lose function and lead to kidney failure. Currently there is no approved therapy for FSGS, although treatment can slow the decline of kidney function.

To be eligible, participants must be between 18 and 70 years of age and have Primary FSGS. Learn more at ClinicalTrials.gov.

Principal Investigator: Anne Pesenson, MD
Sub-Investigator: Lisa Nakamoto, MD
Study Coordinator: Shannon Yedinak, MA-C

Restless Legs Syndrome

Dr. Meghana Doreswamy is conducting a multi-center study evaluating Injectafer® for the treatment of Restless Legs Syndrome in patients with Iron Deficiency Anemia. Injectafer® is FDA approved for the treatment of Iron Deficiency Anemia, but its use in the treatment of Restless Legs Syndrome is investigational. Restless Legs Syndrome is a condition that causes an uncontrollable urge to move your legs, usually because of an uncomfortable sensation.

To be eligible, participants must be 18 years of age or older and have Restless Legs Syndrome and Iron Deficiency Anemia. Learn more at ClinicalTrials.gov.

Principal Investigator: Meghana Doreswamy, MD
Sub-Investigator: Braden Nago, MD
Study Coordinator: Nicole Davis-Ducksworth, CMA

Rheumatoid Arthritis

Dr. Anthony Krajcer is conducting a multi-center study further evaluating how the use of Vectra DA test scores may impact treatment decision in patients with Rheumatoid Arthritis (RA). Vectra DA is an approved blood test that measures the levels of 12 biomarkers (markers in the blood) that have been linked to inflammation. These biomarker levels are combined into a single score that indicates the current level of RA disease activity. The single score classifies RA into low, moderate, and high disease activity. Tracking Vectra DA scores over time can complement assessments of how a patient’s RA is responding to treatment.

To be eligible, participants must be 18 years of age or older and have active Rheumatoid Arthritis despite previous treatment with methotrexate. Learn more at ClinicalTrials.gov.

Principal Investigator: Anthony Krajcer, MD
Study Coordinator: Nicole Davis-Ducksworth, CMA

Ulcerative Colitis

Dr. Peggy Headstrom is conducting a multi-center study evaluating an investigational drug in inducing remission of Ulcerative Colitis in patients who have active disease despite current or previous treatments. Ulcerative Colitis is an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. Symptoms usually develop over time. Ulcerative Colitis can be debilitating and can sometimes lead to life-threatening complications. Currently there is no cure, although treatment can reduce disease symptoms and even result in long-term remission.

To be eligible, participants must be between 18 and 75 years of age and have moderate to severe active Ulcerative Colitis despite current or previous treatments. Learn more at ClinicalTrials.gov.

Principal Investigator: Peggy Headstrom, MD
Sub-Investigator: Craig Pepin, MD
Study Coordinator: Shannon Yedinak, MA-C