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Clinical Core

The Clinical Core is integral to Duke CFAR activities by providing access for investigators to specified and carefully characterized populations of people with HIV (PWH); providing expert assistance in study design, implementation, and regulatory support; identifying new scientific opportunities based upon novel clinical observations; promoting interdisciplinary team science; and engaging investigators new to HIV/AIDS research. We emphasize bidirectional communication and engagement with communities of researchers and PWH in North Carolina and Tanzania through our Community Advisory Boards (CABs).

Particularly valuable for new and/or young investigators.
Services Offered

If you would like to request a service from the Clinical Core, please fill out this Service Request Form and email it to cfar-clinical-core@duke.edu

The Clinical Core services fall into 5 broad categories:
Consultation on study design, implementation, analysis and manuscript preparation
 
Drs. Cunningham and Bartlett are highly experienced clinical investigators, and their experience offers a great service to laboratory-based investigators and junior investigators who need human subjects for their research. They average 20 consultations on studies per year. These consultations may provide input on study design, study interventions, study outcome measures, appropriate subject populations, project implementation, adverse events, study analysis, interpretation of results, and publication of manuscripts.  

Clinical Research Support
The Clinical Core can assist with a number of issues related to the conduct of specific research studies. This may include consultations on study design, study feasibility and recruitment and retention issues. In addition, study coordinator assistance may be available for some studies. Salary support is requested for study coordinator assistance whenever possible. Stuart Carr has been working with various study teams on these issues for a number of years.
           
Regulatory Support    
Regulatory compliance is essential by all Duke CFAR investigators, and the Clinical Core provides expertise and assistance in ensuring compliance.  Regulatory support is the service most commonly requested by Clinical Core Users, and approximately 100 users access this service annually.  Given the number of international studies and the number of countries in which CFAR investigators are engaged in research, the management of regulatory compliance has become enormously complex. The CFAR Clinical Core can assist international partners with requirements for DUHS IRB submissions, human subject protection training, and other specific requirements related to their research. Stuart Carr and Kathy Link have many years of regulatory experience working with various types of studies in the United States and internationally. 
                    
Database and Biorepository Access  
The Clinical Core has established a database and biorepository. This Database includes nearly 1900 HIV-infected persons receiving care in the Duke University Adult Infectious Diseases Clinic and will soon include approximately 100 HIV-infected children and adolescents receiving care in the Pediatric Infectious Diseases Clinic.  The demographics of these patient populations mirror the reported demographics for North Carolina (57% African American and 28% women). There are currently over 70,000 plasma samples in this biorepository.

For more detailed information, please click here.
 
Community Engagement
The Clinical Core supports Community Advisory Boards (CABs) in Durham, North Carolina and in Moshi, Tanzania.  The CABs provide CFAR investigators with an important opportunity to interact with the community and receive feedback on study proposals and to disseminate research results back to the community.  The Durham CAB meets every two months.  The Moshi CAB meets monthly, and it has separate meetings for a Youth CAB.  These CABs have been active within the National CFAR CAB Coalition, attending meetings in Philadelphia, Seattle and Boston and participate on conference calls.  Julieta Giner is the Durham CAB liaison. Bona Shirima is the Moshi CAB liaison. Both have many years of experience working with the HIV- infected and HIV-affected communities.

Open and Enrolling HIV Related Studies at Duke

HIV and Heart Disease
A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention (EXTRA-CVD)
Purpose: The purpose of this study is to find out how we can improve blood pressure and cholesterol treatment for people living with HIV who are on HIV medication.
Protocol Summary: If you decide to participate in this study, you will be asked to come to your HIV clinic for research visits every 4 months for one year (4 total visits). You will be randomly assigned to one of two groups- the nurse intervention group or the education control group. If you are assigned to the nurse intervention group, you’ll meet with the nurse on the day you enroll to complete a health risk assessment, review your medications, and discuss adherence treatments recommended by your doctor. Similar in-person visits will occur every 4 months for a year. You’ll also receive a home blood pressure monitor and work with your nurse
over the next year to get better control of your blood pressure and cholesterol. If you are assigned to the education control group, you’ll meet with the nurse in person every 4 months over the next year. You’ll discuss topics such as diet, exercise, sexually transmitted infections, etc.
Eligibility: Persons living with HIV who have both high blood pressure and high cholesterol
Location: Duke Clinic 1K
Contact: Kiran Grover 919-668-1095

HIV and Kidney Disease
Long-term Consequences of HIV in the Kidney: Core C
Purpose: The purpose of this study is to collect blood and stool specimens and clinical data on HIV+ people with Stage 1, 2 or 3 chronic kidney disease. These specimens will support research into the long-term consequences of chronic HIV infection in the kidney, including the role of HIV infection in promoting kidney disease and the potential for the kidney to serve as a reservoir for the virus.
Protocol Summary: After the consent process, participants will have one blood draw. There will be one survey to complete. They will be given a prepaid shipping box with supplies and instructions for stool collection. The collection will occur at home. They will be able to mail the box directly to the processing lab.
Eligibility: HIV+, 18 or older, non-diabetic with stage 1, 2 or 3 chronic kidney disease and who are in active follow up at Duke for their HIV infection.
Location: Duke Clinic 1K
Contact: Stuart Carr, 919-668-4849

HIV and Cognitive Function
Project BRAIN
Purpose: HIV infection and drug use can each affect the immune system and the brain, which in turn may affect cognitive functioning (for example, memory, attention, reasoning). The purpose of this study is to compare these processes in individuals with HIV infection who use cocaine only, marijuana only, both cocaine and marijuana, or neither drug.
Protocol Summary: Participants will have up to four visits. Part 1 (Neurobehavioral Assessment) includes a screening visit, questionnaires, a mock MRI scan, neuropsychological tests, and a brain MRI scan. A subset of participants who complete Part 1 will be asked to participate in Part 2 (Immune Profiling Assessment).
Eligibility: At least 18 years old, HIV-positive, willing to have an MRI
Location: Duke Clinic 1K
Contact: Ally Odom, 919-668-9324
 
Non-Interventional
HIV Cure Study: Risk, Risk Perception, and Ethics (HIV Cure Survey) Medical Decision Making for Participants in Clinical Research   
Purpose: This study is being conducted to understand the attitude of individuals with HIV who are on long-term antiretroviral (ARV) medications toward experimental trials aiming to cure HIV. The study is particularly interested in how stigmatization, personal relationships, future health concerns, and general trust in clinical research may motivate a person’s decision to risk going off their stable medication regimen for curing HIV. This information is important to ensure that future trials are conducted in an ethically sound manner.
Protocol Summary: A total of 100 HIV+ patients from the Duke HIV clinic will be enrolled. Once eligibility is determined, the informed consent process will occur followed by the subject completing the survey on an iPad. The visit should take about 45 minutes to complete.
Eligibility: HIV+, 18 or older, fluent in English, competent to give informed consent, have been on ARV therapy for more than 6 months, have had a suppressed viral load for at least 12 months, do not currently have any type of cancer and do not currently have any HIV-related opportunistic infections.
Location: Duke Clinic 1K
Contact: Stuart Carr, 919-668-4849

HIV Treatment Study for Minors
Gilead GS-US-380-1474
Purpose: The main purpose is to evaluate the pharmacokinetics (PK) for GS-9883 and confirm dose in this age population, and to evaluate its safety and tolerability.
Protocol Summary: This is a Phase 2 open label PK, safety, and antiviral activity of GS-9883/Emtricibine (F)/Tenofovir Alafenamide (TAF) fixed dose combination in HIV-1 infected virologically suppressed adolescents and children. There are two parts and three different age/weight groups (cohorts) to the study. Part A is 2 or 4 week intensive PK to evaluate the GS-9883 after which study participants will receive the GS-9883/F/TAF through a minimum of 48 weeks or until commercially available. Part B is treatment only phase. Subjects will receive GS-9883/F-TAF for a minimum of 48 weeks or until commercially available. Age cohort 1 (12 to less than 18 years of age will enroll into Part A and B. Age cohort 2 (6 to less than 12 years of age) will enroll into Part A and B. Age cohort 3 (2 to less than 12 and less than 25 kilograms) will be enroll into Part A. Cohorts 1 and 2 Parts A and B have closed to accrual. Cohort 3 Part A has closed to accrual. Cohort 3B will open to enrollment in October 2019.
Eligibility: HIV positive, 2 to less than 18 years of age, with an HIV viral load less than 50 copies/ml on a stable HIV treatment regimen for at least 6 months prior to screening. 
Location: Duke Children’s Health Center
Contact: Julia Giner (919) 668-4844

Core Staff Contact

Leadership:
John Bartlett, M.D. 
Clinical Core Director           
jab5@duke.edu
(919) 681-8043

Coleen Cunningham, M.D. 
Clinical Core Co-Director
coleen.cunningham@duke.edu  
(919) 668-6335            

Stuart Carr
Clinical Core Study Coordinator
stuart.carr@dm.duke.edu
(919) 668-4849

Katherine Link, RN  
Clinical Core Regulatory Coordinator
Katherine.link@duke.edu
(919) 668-0161

Julieta Giner, RN ACRN
Clinical Core Community Outreach Coordinator 
julieta.giner@duke.edu 

Clinical Core group email: cfar-clinical-core@duke.edu