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Clinical Core

The Duke CFAR Clinical Core brings together extremely knowledgeable clinical researchers, outstanding basic scientists and experienced and efficient coordinators who can facilitate interactions, study implementation, IRB submission, regulatory compliance and recruitment.  This resource has been particularly valuable for new and/or young investigators who are not yet familiar with patient clinic set-ups and how to access samples appropriately.  It is through these interactions and through the provision of clinical research and regulatory expertise that we can best facilitate new, novel, and important clinical and basic science research at the Duke CFAR.  

Particularly valuable for new and/or young investigators.

Services Offered

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 60,000 plasma specimens in this biorepository.
 
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 Asthma

Effects of HIV on lung inflammation and lung function in patients with and without asthma

Purpose: The purpose of this study is to look at the effects of HIV on lung function and airway inflammation in patients with and without asthma. At this time we are only enrolling patients with HIV who do not have asthma and who do NOT smoke tobacco products or e-cigarettes. The study is for research purposes only.
Protocol Summary: The study will enroll 10 patients. There is one study visit. Participants will undergo a screening physical, lung function testing, sputum induction and a lab blood draw.
Eligibility: HIV+, ≥18 to <64 years of age, non-smoker, taking antiretroviral drugs consistently for greater than 9 months, not on antibiotics and able to come in for study visits.
Location: Clinic Duke AAAC
Contact: Noely Martinez-Overby, Phone: 919-613-7699

 

HIV and E-cigarettes

Effects of e-cigarettes (ECIGs) on pulmonary inflammation and behavior in HIV infected smokers

Purpose: The purpose of this study is to determine what effects using e-cigarettes (ECIGs) rather than regular tobacco cigarettes have in people with HIV. The study is also interested in asking participants their opinions on the use of ECIGs. This study is for research purposes only. It is not a quit smoking study.
Protocol Summary: The study will enroll 20 people. A total of 15 will be assigned to receive ECIGs for a 4-week period and 5 will be assigned to continue smoking their regular brand of regular cigarettes. Participants will use a cell phone and carbon monoxide monitor to record carbon monoxide levels and mood. There will be 5 study visits (some lasting up to 4 hours) after enrollment over an 8-week period.
Eligibility: HIV+, ≥18 to <64 years of age, tobacco cigarette smoker, taking antiretroviral drugs consistently for greater than 9 months, willing to use only ECIGs for 4 weeks if assigned to that group and able to come in for study visits.
Location: Clinic 1K
Contact: Stuart Carr, 919-668-4849

 

Acute HIV Infection

PHI 05

Purpose: The main purpose of this study is to test how well a fixed-dose combination (FDC) of three antiretroviral HIV drugs (drugs used to treat the HIV virus) work in persons diagnosed with HIV very soon after they are infected (during acute HIV infection).
Protocol Summary: This is a single arm, multi-center, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) started during acute HIV infection (AHI).
Eligibility: Men and women 18 years of age or older who are newly diagnosed with AHI, and enrolled within 30 days of their AHI diagnosis.
Location: Duke Clinic 1K
Contact: Kara McGee, PA-C 919-668-0242

 

HIV and Heart Disease

Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE

Purpose: The main purpose of this study is to see if pitavastatin, a cholesterol lowering drug, can prevent heart disease and heart-related deaths in people with HIV infection who are taking antiretroviral HIV drugs.
Protocol Summary: In this study, people between the ages of 40 to 75 with HIV will be randomized (like the flip of a coin) to take the pill pitavastatin OR a placebo (a pill that looks like pitavastatin but contains no active drug) to see if pitavastatin can help prevent heart disease and death in people who are taking antiretroviral HIV drugs. The study lasts approximately 72 months and study participants will not know if they are taking pitavastatin or placebo.
Eligibility: HIV positive people between the ages of 40 to 75, taking antiretroviral HIV drugs for 6 or more months and have no history of heart disease.
Location: Duke Clinic 1K
Contact: Emily Hecker, RN, MSN 919-668-5142

 

HIV and Solid Organ Transplantation

Solid Organ Transplantation and the Use of RAL in HIV-Infected Patients                

Purpose: The main purpose of this study is to look at the role of raltegravir (RAL) in the management of HIV-infected persons listed for solid organ transplantation, with a focus on those who receive kidney transplants.
Protocol Summary:This is an observation study that will consist of two study groups; one for people who join the study before or pre-transplant and the other for people who join the study after or post-transplant. The amount of time that a person participates in this study will vary with the maximum study duration being 24 months. The study aims to determine the effect of raltegravir on both pre- and post-transplant HIV infected subjects.
Eligibility: HIV positive adults who have either received an organ transplant or are on the active wait list for a solid organ transplant. Must have CD4 count >200/μL, at least 24 months of having low HIV viral loads of <50 copies/mL for the majority of the time and currently taking raltegravir for control of HIV infection.
Location: Duke Clinic 1K
Contact:Dr. Cameron Wolfe 919-668-0789

 

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 two different age groups (cohorts) to the study. Part A is 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 1.  Enrollment into Part 2 for age cohort 2 will be delayed in opening. 
Eligibility:HIV positive, 6 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

 

HIV and Cognitive Function

Study title: 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: Emily Hecker, RN, MSN (919) 668-5142

 

Non-Interventional

Patient Perspectives on Chronic Disease Care in HIV-Infected Persons 

Purpose: The purpose of this study is to determine patient perspectives on how non-HIV related chronic disease care is delivered to HIV-infected persons
Protocol Summary: The study consists of participating in a one on one interview with a study coordinator lasting approximately 30 minutes. We will ask questions about the study participants’ experiences in receiving chronic disease care as an HIV-positive person and their opinions on how to make it better.
Eligibility: HIV positive adults age 40 or older taking antiretroviral HIV drugs who have received care at the Duke Infectious Diseases Clinic for HIV infection for 2 or more years.
Location: Clinic 1K
Contact: Laura Mkumba, 919-668-0165

Research Highlights

Postnatally-transmitted HIV-1 Envelope variants have similar neutralization-sensitivity and function to that of nontransmitted breast milk variants.

Funding:  5P30 AI064518 Duke Center for AIDS Research Grant
Publicaton: Fouda et al Retrovirology 2013

PMTCT Performance in HIV-infected Pregnant Women in Tanzania

Funding: NOT-AI-10-023
Publication: Buchanan et al. PLoS One, in press

HIV Infection and Cervical Cancer Screening

Funding: R25CA057726
Publications: Nye et al. PLoS One 2013; Vidal et al. Infectious Agents and Cancer 2011

Predicting Virologic Failure in HIV-infected Children in Tanzania

Funding: CFAR Small Grant
Publication: Emmett et al. Journal of AIDS 2011

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

Patricia Bartlett, MSW
Clinical Core Community Outreach Coordinator 
pab5@duke.edu