A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications. Protocol #: 19-2824 Location: University of Colorado Hospital |
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses. Protocol #: 19-1403 Location: Childrens Hospital Colorado |
A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients - NYMC 579Protocol #: 19-0858 Location: Childrens Hospital Colorado |
A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1Protocol #: 18-2315 Location: University of Colorado Hospital |
An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical VentilationThe study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug. Protocol #: 18-1706 Location: University of Colorado Hospital |
A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018Protocol #: 18-1493 Location: University of Colorado Hospital |
A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile InfectionPrimary Objective: To confirm the efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI through 8 weeks. Secondary Objective: To evaluate the sustained clinical response rate of RBX2660 as compared to Placebo after blinded treatment. Protocol #: 18-1344 Location: University of Colorado Hospital |
Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherenceProtocol #: 18-0715 Location: University of Colorado Hospital |
A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase InhibitorsProtocol #: 17-2431 Location: University of Colorado Hospital |
Mitochondria in HIV and Aging (MITO+)The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Protocol #: 17-2161 Location: University of Colorado Hospital |
The relationship between the gut microbiome composition and pulmonary immune function in HIV infectionProtocol #: 17-1512 Location: University of Colorado Hospital |
Anal Cancer/HSIL Outcomes Research (ANCHOR) StudyProtocol #: 15-1466 Locations: Denver Health Medical Center; University of Colorado Hospital |
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDERProtocol #: 16-2718 Location: University of Colorado Hospital |