What is the Infectious Diseases Clinical Trials Unit?
The Ohio State Infectious Diseases Clinical Trials Unit (IDCTU) conducts federally sponsored research studies for the treatment of HIV and AIDS, COVID-19, and other infectious diseases. The unit is stffed by an expert, multidisciplinary team of health care professionals.
The IDCTU is one of 76 global sites within the AIDS Clinical Trials Group (ACTG). The ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. The IDCTU has conducted studies within a variety of networks including but not limited to the HIV Prevention Trials Network (HPTN), the MACS/WIHS Combined Cohort (MWCCS), GILEAD Sciences, AstraZeneca and Atea Pharmaceuticals.
Education and Training
The IDCTU provides multidisciplinary education and custom designed training and technical assistance to support, motivate and educate physicians, nurses, physician assistants, dental professionals, pharmacists, advanced practice nurses, and members of the clinical team to provide quality HIV care. Additional trainings are provided to Ryan White funded staff from across the state. Our services help improve the quality of life for individuals with HIV/AIDS.
Examples of trainings include:
- Introduction to HIV
- HIV Medications Update
- Opportunistic Infections
- PrEP and STI PEP
Community Advisory Board – A Voice for Our Volunteers
As part of the AIDS Clinical Trials Group, the IDCTU has a Community Advisory Board (CAB) providing advocacy and partnerships for affected communities, especially clinical trial participants. We encourage participants to ask questions about the research process and share their ideas and concerns. The CAB is open to all who are interested.
Want to join our CAB?
Call 614-293-6725 or email David.Andrist@osumc.edu.
Our Enrolling Research Studies
The IDCTU has several currently enrolling studies that are in need of participants. Click the drop down for each study below to find out more and for contact information.
This study is a one-time blood draw that will be stored for possible currently unspecified genetic analysis. This study is open to any participant already enrolled or previously enrolled in an ACTG study at the IDCTU.
Contact any of the IDCTU’s site staff for more information about this study if you have already participated or plan to participate in another ACTG study.
This is an observational study that has historically looked at why HIV continues to be present in people who are taking anti-HIV drugs. The current version of this study will enroll people who have acquired HIV while taking drugs to prevent HIV and will help researchers understand why this happened.
Contact the study lead at Heather.Harber@osumc.edu or 614-293-7299 if you are interested in this study.
This is a randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of therapeutic vaccination in a sequential regimen with TRL7 agonist vesatolimod and two bNAbs in individuals with HIV who started ART during acute HIV infection. This study consists of four steps including an analytic treatment interruption.
Contact the study lead at Robyn.Patrick@osumc.edu or 614-293-4028 if you are interested in this study.
The purpose of this study is to investigate whether N-803, a new experimental drug that causes the immune system to work harder, is safe and tolerable when given alone and in combination with two new experimental drugs that are antibodies to HIV. This study will also look at how well HIV is controlled after stopping anti-HIV medication.
Contact the study lead at Jessica.Marburger@osumc.edu or 614-293-4663 if you are interested in this study.
This is a randomized, double-blind placebo-controlled study to evaluate whether two bNAbs combined with ART initiation during acute HIV infection (AHI) will induce HIV remission. The study involves four steps including an analytic treatment interruption (ATI).
Contact the study lead at Kurt.Wolfe@osumc.edu or 614-293-4669 if you are interested in this study.
The purpose of this study is to see if an investigational vaccine called ‘Trimer 4571’ is safe and well tolerated in people living with HIV who are on a suppressive ART regimen and to see if it will help the body’s immune system respond to HIV.
Contact the study lead at Korin.Reed@osumc.edu or 614-293-5856 if you are interested in this study.
The purpose of this study is to evaluate how well tecovirimat works for treatment of human monkeypox virus infection and if the study drug is safe in people. The study will also help researchers understand more about how human monkeypox causes disease and how the body fights off infection.
Contact the study lead at Lindsay.Summers@osumc.edu or 614-293-8529 if you are interested in this study.
Notable Studies & Results
The IDCTU has participated in several historic studies that have improved HIV treatment and prevention over the years. Since 2020, the IDCTU has made significant contributions to COVID-19 treatment and prevention studies as well. Check out some of these studies below.
The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) trial was designed to address the increased risk of heart disease experienced by people living with HIV. REPRIEVE tested pitavastatin calcium, a statin medication that can lower LDL cholesterol and reduce inflammation in the body.
Pitavastatin was found to be effective at lowering the rate of heart disease events for people living with HIV at low-to-moderate traditional risk for heart disease. REPRIEVE is the first large-scale trial to test a heart disease prevention strategy in this population. Read more about results and implications of this trial here: reprievetrial.org.
HPTN 083 was the first study to compare the efficacy of long-acting cabotegravir (CAB-LA) to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention. The study enrolled 4,570 cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men at sites across the globe. Results from the study found that CAB-LA was superior to TDF/FTC among MSM and TGW who have sex with men.
Data from this study and another study, HPTN 084, helped provide important information for the FDA to approve ViiV Healthcare’s CAB-LA injections for the prevention of HIV. Learn more about the HPTN 083 study here: giveprepashot.org.
The HAILO study was developed to look at relationships between living with HIV, a person’s age and their immune system, and how these influence the development of conditions such as heart disease, kidney disease, cancer, memory problems, and diabetes. The study also looked at how demographic factors, behaviors, and social factors impact the risk for development of various illnesses or death. The study came to a close in 2021 and enrolled a total of 1,035 participants across various research sites, including the IDCTU.
A5379 is an active study at the IDCTU that is no longer enrolling participants. This study is looking at hepatitis B vaccination in adults living with HIV and will determine whether a new approved vaccine, called HEPLISAV-B, will prove to be more effective than the current standard. The study is already showing success with data showing a three-dose regimen of HEPLISAV-B vaccine fully protecting people living with HIV. The FDA approved the HEPLISAV-B vaccine in 2017 as a two-dose regimen for adults, but until now, there has been little data around its use among people living with HIV.
The National Institute of Allergy and Infectious Diseases (NIAID) created the COVID-19 Prevention Network (CoVPN) using the infectious diseases expertise at four of its existing clinical trials networks. The IDCTU is a member of two of those NIAID-funded networks and was a site for the AZD1222 COVID-19 vaccine study that enrolled over 30,000 participants globally. The vaccine was co-developed by the University of Oxford and AstraZeneca, a biopharmaceutical company. The study was a success globally with AstraZeneca releasing over 3 billion doses of the vaccine, now called Vaxzevria, to more than 180 countries. Approximately two-thirds of the doses were delivered to low- and lower-middle income countries.
Red Ribbon Registry
The Red Ribbon Registry is a database of volunteers who are interested in participating in HIV/AIDS clinical trials. The registry connects volunteers with local clinical studies to strengthen the connection between the community and the doctors and scientists working to end HIV.
Visit the Red Ribbon Registry website to learn more and sign up.
Our Investigators
IDCTU Staff
Lindsay manages the IDCTU research staff and coordinates studies conducted at the IDCTU. Contact Lindsay for more information about the research unit and any of our trials.
Lucy handles all regulatory components for each of the IDCTU’s research studies. She also leads the data team acting as Data Manager for all research studies. Contact Lucy for questions related to regulatory or research data.
Isaac is a member of the data team alongside Lucy Niermann and performs data entry on nearly all of our research studies.
Tami has a variety of responsibilities that ensure the administrative functions of research operate smoothly.
David assists with outreach and recruitment efforts for studies conducted at the IDCTU. He also provides training opportunities and coordinates the community advisory board. Contact David about any of our enrolling studies.
Korin works on a variety of research studies at the IDCTU, primarily focusing on HIV treatment studies. Contact Korin for more information on enrolling study, NETI.
Heather works on several research studies, varying from HIV treatment and prevention studies to COVID treatment studies. Contact Heather for more information on enrolling study, A5321.
Jessica has worked on a variety of ACTG and industry studies, including HIV and COVID treatment studies. Contact Jessica for more information on enrolling study, A5386.
Kurt led our efforts on the AZD1222 COVID vaccine study and has now expanded his work into HIV prevention and treatment studies. Contact Kurt for more information on enrolling study, A5388.
Allison’s primary focus is the MWCCS Combined Cohort Study, which is an observational study enrolling men and women with HIV.
Robyn works on several research studies, varying from HIV treatment and prevention studies to COVID treatment studies. Contact Robyn for more information on enrolling study, A5374.
Brian has been a part of the IDCTU for several years and manages the research lab team. Contact Brian for any lab related questions or inquiries.
Carissa is a member of the research lab team. Carissa works on all of the IDCTU’s studies processing specimens and assisting with lab activities.
Rebecca is a member of the research lab team. Carissa works on all of the IDCTU’s studies processing specimens and assisting with lab activities.
Social Media
Check out our social media accounts!
Instagram: @ohiostateactu
Twitter: @osuactu