Effect of Antiretroviral Therapy on Stool Microbiome in Treatment Naive HIV Infected Adults Save

Date Added
September 21st, 2017
PRO Number
Pro00069909
Researcher
Edwin Hayes
Keywords
HIV / AIDS
Summary

This is a prospective, observational study to compare the changes in stool microbiome of HIV positive treatment naive or who have not been on ART for at least 6 months subjects pretreatment and 12 weeks after initiation of ART. Subjects will be recruited at the Immunology Center Clinic of Palmetto Health/ University of South Carolina located in Columbia SC.
Adults >18years with serologically documented HIV infection and no prior ART use for pre exposure or post exposure prophylaxis within the last 6 months will be included in the study

Institution
Palmetto
Recruitment Contact
Edwin Hayes
8035455350
Edwin.Hayes@uscmed.sc.edu

HIV-associated Obstructive Pulmonary Disease and Emphysema Save

Date Added
August 15th, 2017
PRO Number
Pro00066169
Researcher
Lynn Schnapp

Silhouette
Keywords
HIV / AIDS, Pulmonary, Smoking
Summary

Emphysema is a type of Chronic Obstructive Pulmonary Disease (COPD) and a major cause of death. Studies suggest that emphysema is more common in HIV positive people (HIV+) compared to HIV negative (HIV-) people. The purpose of this research study is to determine whether emphysema in HIV+ patients is clinically and biologically different compared to emphysema in those without HIV.

Institution
MUSC
Recruitment Contact
Mary Blanton
8437928438
blantonm@musc.edu

Evaluation of the CytoRADx SystemTM as a Biodosimeter for Special Human Populations Save

Date Added
July 14th, 2017
PRO Number
Pro00067066
Researcher
Gary Headden

Silhouette
Keywords
Blood Disorders, Children's Health, Environmental Factors, HIV / AIDS, Non-interventional, Pediatrics
Summary

This is a study to develop a test for radiation exposure in the event of a nuclear event such as the detonation of a nuclear device or widespread radiation exposure. We will collect blood samples from a variety of different types of human subjects whose current medical status could possibly have an effect on the results of the test, such as trauma, burns, infections or a damaged immune system or young children. The goal is to ensure that these conditions do not affect the results of the test.

Institution
MUSC
Recruitment Contact
Robert Houck
(843) 792-3576
houckr@musc.edu

Gilead Sciences, Inc. GS-US-380-4030: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed Save

Date Added
July 13th, 2017
PRO Number
Pro00066825
Researcher
Helmut Albrecht
Keywords
Drug Studies, HIV / AIDS, Infectious Diseases
Summary

This Phase 3 protocol is a randomized, double-blind, study evaluating the safety and efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral resistance. Male and female HIV-1 infected patients greater than or equal to 18 years of age currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF may be eligible to participate in this study.

University of South Carolina School of Medicine
Two Medical Park, Suite 502
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Helmut Albrecht, MD at 803-540-1000

Institution
Palmetto
Recruitment Contact
Helmut Albrecht
803-540-1000
ClinicalTrialSurvey@PalmettoHealth.org

IMPACT OF INTEGRATED HIV/NCD SCREENING ON HIV TESTING UPTAKE AND ENGAGEMENT IN HIV CARE: AN RCT IN KISARAWE, TANZANIA Save

Date Added
July 5th, 2017
PRO Number
Pro00064733
Researcher
Michael Sweat

Silhouette
Keywords
Diabetes, HIV / AIDS, Hypertension/ High Blood Pressure
Summary

HIV testing is often shunned in community settings due to the stigma of HIV-centric services. Our recent pilot study strongly suggest that integration of a package of screening that include HIV, diabetes, and hypertension hold promise of substantially increasing the uptake of HIV testing while simultaneously providing direly needed community screening for non-communicable disease (NCDs) like diabetes and hypertension, which themselves are at epidemic levels in Sub-Saharan Africa. This study will examine whether integrating HIV screening with NCD screening will improve uptake of HIV testing and whether integrating HIV and NCD care will improve retention.

Institution
MUSC
Recruitment Contact
Michael Sweat
843-876-1082
sweatm@musc.edu

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed Save

Date Added
June 13th, 2017
PRO Number
Pro00066778
Researcher
Eric Meissner

Silhouette
Keywords
HIV / AIDS
Summary

This clinical research study is looking for men and women 18 years of age or older to test and evaluate the safety and effectiveness of an investigational combination medication for adults living with HIV.
Volunteers must be diagnosed with HIV-1 and on certain treatment regimens for HIV for at least the past 3 months. Those who qualify will take study medication for at least 48 weeks (almost 1 year). This medication will either be the investigational medication or an FDA approved medication for HIV. Subjects will receive all study-related care at no cost.

Institution
MUSC
Recruitment Contact
Tamara Jenkins
(843) 792-5491
saundert@musc.edu

Feasibility and acceptability of an mHealth cognitive behavioral stress management intervention to ameliorate HIV-related fatigue Save

Date Added
August 25th, 2016
PRO Number
Pro00057504
Researcher
Julie Barroso

Silhouette
Keywords
HIV / AIDS, Stress Disorders
Summary

HIV-related fatigue is a serious problem for those infected with the virus. We believe that cognitive behavioral stress management is a good solution since stress is the most consistent predictor of increases in fatigue for this group. We want to convert an already proven curriculum to an mHealth format to extend the reach of this intervention.

Institution
MUSC
Recruitment Contact
Julie Barroso
843-792-2110
barroso@musc.edu

Immune response to pneumococcal vaccination in aging HIV positive adults Save

Date Added
November 17th, 2015
PRO Number
Pro00046749
Researcher
Maria anna Westerink

Silhouette
Keywords
Aging, Blood Disorders, Healthy Volunteer Studies, HIV / AIDS, Infectious Diseases, Vaccine
Summary

We are doing this study to find out what practice, one dose PPV23 or one dose PCV13 followed by one dose PPV23, protects better against pneumonia in older HIV-positive.

Institution
MUSC
Recruitment Contact
Myroslawa Soloshchenko
8437922218
soloshch@musc.edu

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy Save

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

Silhouette
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
Stephanie Warth
843-792-5491
warth@musc.edu

Randomized Trial to Prevent Vascular Events in HIV ? REPRIEVE (A5332) Save

Date Added
June 16th, 2015
PRO Number
Pro00042920
Researcher
Allison Eckard

Silhouette
Keywords
Cardiovascular, Cholesterol, Disease Prevention, Drug Studies, Heart, HIV / AIDS, Infectious Diseases
Summary

Pitavastatin lowers high cholesterol and triglyceride levels in the blood. The primary purpose of this study is to determine the effects of pitavastatin on lowering the traditional risk factors for cardiological events in patients who have HIV.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-792-5491
warth@musc.edu

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