A Phase 2a Multicentre, Randomized, Open-Label, Two-Part Adaptive Design Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A, an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naive HIV-1-Infected Adults

Date Added
June 15th, 2021
PRO Number
Pro00110807
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational drug in adults with a clinical diagnosis of Human Immunodeficiency Virus (HIV). This study aims to determine if receipt of a one-time infusion or sub-cutaneous (under the skin) administration of the study drug results in a longer lasting response against HIV. The study drug will be given in addition to the standard of care treatment. The study of this investigational drug represents a novel approach to the treatment of this condition. Participation in the study will involve a minimum of 10 visits to the study clinic over a period of 1 month, followed by initiation of standard of care treatment.

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

Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Date Added
February 22nd, 2021
PRO Number
Pro00105369
Researcher
Carla Danielson

List of Studies


Keywords
Adolescents, HIV / AIDS, Substance Use
Summary

Human subjects are being recruited for the proposed study to participate in usability testing for a virtual reality technology tool to be refined for assessment and prevention of risky sexual and substance use behaviors. Specifically, 15 adolescents, 15 young men, and 15 front line health care providers will participate in qualitative interviews and focus groups. Targeted enrollment is based on estimates from the existing clinical population treated by the local clinics from which participants will be recruited and the candidate's experience conducting clinical studies at these sites.

Institution
MUSC
Recruitment Contact
Nathalie Slick
843) 408-6140
slick@musc.edu

Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes

Date Added
February 2nd, 2021
PRO Number
Pro00106801
Researcher
Cristina Lopez

List of Studies


Keywords
Anxiety, Depression, HIV / AIDS
Summary

The purpose of this study is to explore the use of a new treatment program to improve medication adherence for people with HIV and PTSD for patients at MUSC Ryan White clinic. Participants will be assigned to one of two groups. Participants in Group A will be asked to attend 12 clinic sessions (twice a week for 6 weeks, 90-minute sessions) via telehealth or in person at the MUSC Ryan White clinic. Participants in Group B will receive a one session adherence intervention (60 minutes) and get the same standard treatment that someone with a trauma history and co-occurring HIV and PTSD symptoms would receive at a local Ryan White clinic. The study is provided at no-cost, and participants may learn useful information and coping skills while being in the study. It is hoped the information that we get from this study will help researchers and clinicians better design treatment programs for people living with HIV and PTSD. Participants will receive study compensation for their time.

Institution
MUSC
Recruitment Contact
Cristina Lopez
843 876-1034
lopezcm@musc.edu

Targeting Parenting to Prevent HIV and Substance Use Among Trauma-Exposed Youth: A Mixed-Methods Needs Assessment

Date Added
March 16th, 2020
PRO Number
Pro00096161
Researcher
Nada Goodrum

List of Studies

Keywords
Adolescents, Alcohol, HIV / AIDS, Mental Health, Psychiatry, Sexually Transmitted Infections (STI), Substance Use
Summary

Many adolescents experience traumatic events, such as child abuse, physical or sexual assault, or witnessing violence. Teens who experience trauma are more likely to have problems with substance use and risky sexual activity. We want to understand how parents can support their teens and help keep them safe after traumatic events.

Institution
MUSC
Recruitment Contact
Nada Goodrum
843-792-8067
goodrumn@musc.edu

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy

Date Added
August 18th, 2015
PRO Number
Pro00046669
Researcher
Eric Meissner

List of Studies


Keywords
Digestive System, HIV / AIDS, Immune System, Infectious Diseases, Liver
Summary

Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.

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



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