A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

Investigate B cell perturbations and immune reconstitution failure in response to antiretroviral therapy in HIV-infected cocaine users

Date Added
August 26th, 2022
PRO Number
Pro00119926
Researcher
Wei Jiang

List of Studies


Keywords
HIV / AIDS, Immune System, Substance Use
Summary

This proposed project is to investigate the role of cocaine use in B cell dysfunctions and poor immune recovery from antiretroviral therapy in HIV.

Institution
MUSC
Recruitment Contact
Wei Jiang
843-876-2457
jianw@musc.edu

PeRsonalizEd immunomodulation in pediatriC sepsIS-inducEd MODS

Date Added
February 22nd, 2022
PRO Number
Pro00116525
Researcher
John Costello

List of Studies


Keywords
Immune System, Pediatrics
Summary

Subjects in the first group will be enrolled in the GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS (GRACE-2) trial, comparing GM-CSF versus placebo. Subjects in the second group will be an observational cohort with no intervention, because this group has very low mortality and morbidity. Subjects in the third group will be enrolled in the Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS) trial, comparing anakinra and placebo. The fourth group, with very severe inflammation,
will be an observational cohort because clinical management of the inflammation
is standard of care, and there is no equipoise about enrolling these children in a placebo controlled trial. The primary outcome of both trials will be duration and severity of organ dysfunction using the cumulative PELOD-2 score, and secondary outcomes will assess health related quality of life and family functioning at 3 and 12 months.

Institution
MUSC
Recruitment Contact
Christian Conley
843-792-1213
conleyc@musc.edu

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies


Keywords
Body Composition, Cardiovascular, Drug Studies, HIV / AIDS, Healthy Volunteer Studies, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu



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