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, and ViiV Healthcare.
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
ACTG 5402: Pramipexole vs. Escitalopram to Treat Comorbid HAND & MDD in HIV+
The purpose of this study is to evaluate the effectiveness of pramipexole extended release versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons living with HIV.
Contact the study lead at Robyn.Patrick@osumc.edu or 614-293-4028 if you are interested in this study.
ACTG 5423: VIR-2218 & VIR-3434 in Chronic HBV Participants with or without HIV
The purpose of this study is to assess the efficacy of two novel hepatitis B virus (HBV) therapeutic compounds used in combination in participants with chronic hepatitis B (CHB) only and participants with CHB and HIV. The goal is to see if the combination of these compounds can lead to a functional or partial cure of HBV.
Opening Summer 2025 - Contact Lindsay.Summers@osumc.edu or call 614-293-8529 to be put on a waiting list for this study.
ACTG 5424: Hormone Therapy for Peri- and Postmenopausal Women Living with HIV
This study is assessing hormone therapy (transdermal estradiol with or without oral progesterone) versus placebo for women living with HIV in the late menopausal transition or early postmenopause with moderate to severe vasomotor symptoms (VMS).
Opening Summer 2025 - Contact Lindsay.Summers@osumc.edu or call 614-293-8529 to be put on a waiting list for this study.
ACTG 5426: Improving Physical Ability and Cellular Senescence Elimination in HIV
The goal of this study is to evaluate the safety and tolerability of dasatinib and quercetin (D+Q) and efficacy of this regimen in improving physical function outcomes in people living with HIV who are frail or prefrail. This study is looking for participants aged 50 years or more who were diagnosed with HIV 10 or more years ago, who are currently on ART.
Opening Summer 2025 - Contact Lindsay.Summers@osumc.edu or call 614-293-8529 to be put on a waiting list for this study.
ACTG 5128: US Genomics Sample Collection
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.
ACTG 5321: The ACTG HIV Reservoirs Cohort (AHRC) 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.
ACTG 5385: An Observational Post-Intervention Cohort Destination Protocol
This is a non-interventional study for participants from qualifying ACTG CURE trials (A5374, A5386, A5388 & A5389) who achieved prolonged viral control off antiretroviral therapy (ART) during an analytical treatment interruption period (ATI). This study will consist of an extended ATI period.
If you are participating in one of our CURE trials, a study lead will inform you of eligibility for A5385.
ACTG 5374: Triple Immune Strategy for HIV Remission
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.
ACTG 5388: Combination HIV-Specific bnAbs Combined with ART Initiation
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.
ACTG 5389: bNAb Combination for People Who Started ART During Acute HIV Infection
This study is evaluating a combination of two bNAbs in people living with HIV who started antiretroviral therapy (ART) during acute infection. Participants will receive treatment prior to undergoing an analytical treatment interruption (ATI).
Contact the study lead at Heather.Harber@osumc.edu or 614-293-7299 if you are interested in this study.
ACTG 5420: Ixazomib to Reactivate HIV and Reduce HIV Reservoir Size
The goal of this study is to determine whether the addition of oral Ixazomib to continued suppressive antiretroviral therapy in people living with HIV can result in latent HIV reactivation and reduce HIV reservoir size.
Opening Spring 2025 - Contact Lindsay.Summers@osumc.edu or call 614-293-8529 to be put on a waiting list for this study.
ACTG 5422: CH505 TF chTrimer Vaccination in Adults with HIV on Suppressive ART
This study is looking to see if an investigational anti-HIV vaccine (stabilized CH505 TF chTrimer) is safe and well-tolerated in people living with HIV on antiretroviral therapy whose viral load is <200 copies/mL. The aim is to see if the vaccine can induce new immune responses in the body.
Contact the study lead at Korin.Reed@osumc.edu or 614-293-5856 if you are interested in this study.
GS-563-5925: Study to Evaluate Oral Weekly Islatravir/Lenacapavir in PLWH
The purpose of this study is to evaluate the efficacy of switching to oral weekly Islatravir/Lenacapavir (ISL/LEN) versus continuing Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in virologically suppressed people with HIV. Participants must be taking B/F/TAF for >6 months to be eligible for this study. Visit the study website for more info.
Contact the study lead at Jessica.Marburger@osumc.edu or 614-293-4663 if you are interested in this study.
ViiV 221611: Study to Evaluate Long-Acting CAB + RPV in viremic PLWH
This study is evaluating the efficacy, safety and tolerability of injectable cabotegravir long-acting (CAB LA) plus rilpivirine long-acting (RPV LA) in participants living with HIV who are viremic (HIV RNA 1,000-100,000). Visit the study website for more info.
Contact the study lead at Heather.Harber@osumc.edu or 614-293-7299 if you are interested in this study.
ViiV 219230: Ultra Long-Acting Injectable CAB in those at Risk of HIV Acquisition
This study is evaluating a new formulation of Cabotegravir LA injected intramuscularly every 4 months. Participants ages 16 and up who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months, may be eligible for this study. Visit the study website for more info.
Contact the study lead at Kurt.Wolfe@osumc.edu or 614-293-4669 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.
Our Investigators
IDCTU Staff
Lindsay manages the IDCTU research staff¬ and coordinates studies conducted at the IDCTU. She also manages regulatory for all IDCTU studies. Contact Lindsay for more information about the research unit and any of our trials.
Korin works on a variety of research studies at the IDCTU, primarily focusing on HIV treatment studies. Contact Korin for more information on study A5422 - chTrimer Vaccination in Adults with HIV on Suppressive ART.
Heather works on several research studies, varying from HIV treatment and prevention studies to COVID treatment studies. Contact Heather for more information on studies A5321, ViiV 221611 and A5389.
Jessica works on a variety of ACTG and industry studies, including HIV and COVID treatment studies. Contact Jessica for more information on studies A5385, A5386 and GS-563-5925.
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 studies A5388 and ViiV 21930.
Allison’s primary focus is the MWCCS Combined Cohort Study, which is an observational study enrolling men and women with HIV. Contact Allison for more information about this study.
Robyn works on several research studies, varying from HIV treatment and prevention studies to COVID treatment studies. Contact Robyn for more information on studies A5374 and A5402.
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. Rebecca works on all of the IDCTU’s studies processing specimens and assisting with lab activities.
Isaac is a member of the data team. He works on all IDCTU studies performing data entry and addressing data related issues.
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.
Social Media
Check out our social media accounts!
Instagram: @ohiostateactu
Twitter: @osuactu