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Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n... |
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Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study
Outpatient CTRC, University of Colorado Hospital Transgender women (TW) are the fastest-growing group of people with HIV (PWH). Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medication in TW... |
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A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
Outpatient CTRC, University of Colorado Hospital Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad... |
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A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Study of Tecovirimat for Human Monkeypox Virus (STOMP)
Childrens Hospital Colorado Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br... |
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PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)
Childrens Hospital Colorado, University of Colorado Hospital The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ... |
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Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men
Outpatient CTRC, University of Colorado Hospital The aim of this study is to determine whether intestinal barrier dysfunction is higher in HIV+ MSM with MS compared to without MS and related to deficiency in butyrate-production and/or activity of mucolytic bacteria in the gut microbiome.... |
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A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ... |
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An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
CTRC Inpatient, University of Colorado Hospital This outpatient study involves recently diagnosed COVID-19 patients to determine if a single infusion of antibodies can help prevent disease progression. In this placebo-controlled trial, 50% of participants will receive the antibodies, while the other half will receive saline. Neither the... |
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An Open_label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
Outpatient CTRC, University of Colorado Hospital The purpose of this research study is to evaluate the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and mild neurocognitive disorder (MND) in people living with HIV (PWH).... |