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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.
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 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.
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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 Treatment Study for Adults
Purpose: The purpose of this study is to test the effectiveness of switching to a United States Food and Drug Administration (FDA) approved HIV drug called, bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed dose combination (FDC) versus continuing on a regimen consisting of 2 Nucleos (t)ide Reverse Transcriptase Inhibitors (NRTIs) and a third agent in HIV-1 infected adults who are virologically suppressed (HIV-1 RNA test less than 50 copies/mL).
Protocol Summary: GS-US-380-4580 is Randomized, open-label, multicenter, active-controlled study ofHIV-1 infected, virologically suppressed African American participants. Participants will be randomized in a 2:1 ratio to one of the following 2 treatment groups: 1. Regimen 1: FDC of B/F/TAF or Regimen 2 : Stay on baseline regimen (SBR)
Eligibility: HIV positive, Age ³ 18 years , Self-describes as Black, African American, or mixed race including Black, Currently receiving an ARV regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months.
Location: Duke Clinic 1K
Contact: June Carbonneau 919-668-0166
HIV Treatment Study for Minors
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 have closed to accrual.
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
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
Cancer and HIV
Improving Access to Cancer Care in the HIV Population: Formative Research to Identify Barriers to Care
Purpose: The goal of the study is to determine the impact of HIV on beliefs about a cancer diagnosis and care-seeking behavior across the continuum of care, from diagnosis to recovery. The first objective is to conduct in-depth interviews of HIV+ patients who have been diagnosed with cancer to identify themes that will generate an evidence base for care-seeking behavior. We will then use information from the interviews to develop preliminary HIV-specific measures on the topic. This study is an important first step to begin to understand why HIV-infected cancer patients are less likely to receive cancer treatment and to develop strategies to improve cancer outcomes in this population. The ultimate goal is to provide patient-centered care specific to the needs of HIV-infected patients and improve overall outcomes from cancer in the HIV population.
Protocol Summary: A sample of 30 HIV-infected cancer patients from the Duke HIV clinic and Duke Cancer Institute Clinics will be interviewed one-on-one to identify the themes associated with barriers to receiving adequate cancer treatment. The interview will take between 60 to 90 minutes.
Eligibility: Enrollment is complete for those who currently have a cancer diagnosis and are currently being treated and for those with a cancer diagnosis who were treated in the past. Only enrolling those who are HIV+, ≥18 or older, had a cancer diagnosis in the past and did not choose treatment or only received partial treatment for whatever reason.
Location: Duke Clinic 1K and Duke Cancer Institute Clinics
Contact: Stuart Carr, 919-668-4849
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: Ally Odom, 919-668-9324
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: Duke Clinic 1K
Contact: Laura Mkumba, 919-668-0165
HIV Cure Study: Risk, Risk Perception, and Ethics (HIV Cure Survey) Medical Decision Making for Participants in Clinical Research (Not Open Yet)
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
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
Publication: Buchanan et al. PLoS One, in press
HIV Infection and Cervical Cancer Screening
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
John Bartlett, M.D.
Clinical Core Director
Coleen Cunningham, M.D.
Clinical Core Co-Director
Clinical Core Study Coordinator
Katherine Link, RN
Clinical Core Regulatory Coordinator
Julieta Giner, RN ACRN
Clinical Core Community Outreach Coordinator
Clinical Core group email: email@example.com