Current Studies
Our clinical trials group hosts a variety of studies focused on HIV and other infectious diseases. We belong to a group of international and local researchers whose combined mission is to find a cure for HIV, reduce the burden of disease due to HIV infection and its complications, and discover new strategies to prevent HIV transmission. We are dedicated to finding new therapies for other infectious diseases such as COVID-19, hepatitis and influenza.
Participation can range from simple, single blood draws to complex, customized treatment therapies – you can decide what is the best fit for you.
Please select the tabs below to view our open studies by category.
Acute HIV Infection
These studies are for people who are diagnosed with HIV as soon as two to four weeks after they contract HIV. This is the initial stage of HIV, and it lasts until the body creates antibodies against the virus. These studies are for people who have not started taking medications known as Antiretroviral Therapy (ART) or who have just started on ART. For more information about Acute HIV please click here.
Unfortunately, we do not currently have any Acute HIV studies open to enrollment. Please check back soon!
HIV CURE-related Studies
Our group has a number of different studies focused towards bringing us closer to a cure for HIV. While our ultimate goal is to find a way to eradicate HIV, we are not there yet. No one who participates in these studies will be cured but our current studies are exploring different ideas that we hope will put us closer to finding a cure. There are varying levels of participation from a single blood draw to procedures to receiving different medications and personalized therapies. The purpose of these studies is to learn more about how the immune system works, where HIV hides in the body, what medications could flush out HIV from its hiding spots, how we can teach a person’s own immune cells to attack HIV, and vaccines to neutralize HIV replication. Different studies require varying amounts of visits, time commitments, potential risks, and financial compensation. To learn more about HIV CURE research please visit the UNC HIV Cure Center Website here. Please see the information below to discover more about the two different kinds of CURE-related studies that we currently offer.
Investigational Medication CURE Studies
These studies use investigational medications ranging from monoclonal antibodies
to vaccines
to personalized therapies to seek a cure for HIV.
A5386
| Study Title | A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption |
| Goal | Evaluate the safety and ability of N-803, an IL-15 superagonist, with or without bNAbs to control HIV once an individual stops anti-HIV medication. |
| Who is eligible to participate | Men and Women living with HIV between 18 and 70 years old. Eligible participants must have been on ART and plasma HIV <50 copies/mL for at least two years at the time of screening. Otherwise generally healthy. |
| Medication | 8 Injections of an IL-15 superagonist, N-803, and potentially 2 infusions of bNAbs, 10-1074 & VRC07-523LS. |
| Duration | Up to 112 weeks (close to 2.5 years) |
| Compensation | All participants will be compensated for their time, travel and parking. |
CM Study
Coming Soon| Study Title | A phase I study to evaluate the safety and immunogenicity of the CHADOX1.HIVCONSV62 - MVA.THIVCONSV4 (C62-M4) or, CHADOX1.THIVCONSV1+C62 - MVA.THIVCONSV3+M4 (C1C62-M3M4) prime-boost regimens in persons with HIV-1 suppressed on antiretroviral therapy |
| Goal | We will evaluate whether giving a person a vaccine, or combination of two vaccines, targeted against HIV is safe and can improve that person’s immune response to HIV. |
| Who is eligible to participate | HIV+ men and women between 18 and 70 years of age (inclusive), with viral suppression on ART and CD4 count greater than or equal to 350 cells/mm³ |
| Medication | Vaccine C62-M4 & Vaccine C1C62-M3M4 |
| Duration | 8 Months |
| Compensation | All participants will be compensated for their time, travel & parking. |
DART 2
Coming Soon| Study Title | A phase I study of MGD020 as a single agent or in combination with MGD014 in persons with HIV-1 on antiretroviral therapy |
| Goal | To determine whether infusions of MDG020 as a single agent or in combination with MGD014 in persons with HIV-1 (PWH) on suppressive antiretroviral therapy (ART) will be safe and well tolerated. |
| Who is eligible to participate | HIV+ men and women between 18 and 70 years of age (inclusive), with viral suppression on ART and CD4 count greater than or equal to 350 cells/mm³ |
| Medication | DART® molecules are bispecific, antibody-based molecules that can bind 2 distinct antigens simultaneously. MGD020 is an HIV-1 env x CD3 DART molecule. |
| Duration | Between 3.5-5 months |
| Compensation | All participants will be compensated for their time, travel & parking. |
Procedure-only CURE Studies
These studies do not involve any interventional medications, but rather involve procedures, such as leukapheresis
or blood draws, to discover information that might put us closer to a cure for HIV.
Unfortunately, we do not currently have any Procedure-only HIV CURE studies open to enrollment. Please check back soon!
HIV Treatment Studies
These particular studies are focused towards individuals who have been diagnosed with HIV. We have a wide variety of studies:
- HIV treatment studies for people who have been on Antiretroviral medication (ART) for at least one year and have an undetectable viral load
- HIV treatment studies for those who have difficulty taking Antiretroviral medication (ART) and maintaining viral suppression
- HIV treatment studies for those who have never taken HIV medication or have stopped for a while
These studies are for people who have been on Antiretroviral medication (ART) for at least one year and have an undetectable viral load.
Some of these studies investigate the effectiveness of new treatment regimens, while others analyze how HIV affects different aspects of a person’s overall health and well-being.
A5391 - The Do IT Study
| Study Title | Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study) |
| Goal | The DO-IT (A5391) Research Study is exploring whether people living with HIV and taking an ART regimen including an integrase inhibitor in combination with TAF/FTC (or TAF/3TC) could gain less weight, or maybe lose weight, after switching to an ART regimen containing Doravirine with either TAF/FTC (or TAF/3TC). Doravirine (DOR) is an FDA-approved drug for the treatment of HIV. |
| Who is eligible to participate | Men and Women living with HIV, greater than 18 years old, currently on an Integrase Inhibitor containing regimen (i.e. Biktarvy, Tivicay, Isentress), and have a BMI greater than 30 kg/m2. |
| Medication | Participants will be randomized to either begin a new ARV regimen including Doravirine OR stay on their current regimen. |
| Duration | Approximately 1 year |
| Compensation | All participants will be compensated for their time, travel and parking. |
A5355
| Study Title | Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex®), in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function |
| Goal | The purpose of this research study is to see if an investigational vaccine for cytomegalovirus (CMV), called Triplex®, is safe when given to people with both HIV and CMV. This study will also collect information on the effectiveness of the Triplex® vaccine to reduce inflammation and immune activation markers compared to a placebo. |
| Who is eligible to participate | Men and Women between the ages of 18 and 65, who are living with HIV and CMV. Must have taken ART medication for HIV >1year prior to enrollment, CD4 >250, and are otherwise generally healthy. |
| Medication | Randomized in a 2:1 ratio to receive either two injections of CMV-MVA Triplex® or placebo administered at study Entry/Day 0 and week 4. |
| Duration | About 2 years |
| Compensation | All participants will be compensated for their time, travel and parking. |
A5379
| Study Title | B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): A Randomized, Controlled Trial of HEPLISAV-B vs. Engerix-B |
| Goal | In participants living with HIV, HEPLISAV-B vaccination given as a 2 dose series will achieve similar levels of immune response compared to standard dose Engerix-B. |
| Who is eligible to participate | Men and Women who are 18 years of age or older who are living with HIV. Group A: People have received at least one HBV vaccination and do not have antibodies against HBV surface antigen (HBsAb). Group B: People who have never been vaccinated for HBV. |
| Medication | HEPLISAV-B Vaccine – either 2 or 3 doses. Engerix-B - 3 doses |
| Duration | 72 weeks |
| Compensation | Visits - $50. Travel & parking compensation are offered as well. |
These studies are for people who have been diagnosed with HIV and either have trouble taking their HIV medications consistently, have stopped or never started taking Antiretroviral medication (ART).
A5359
| Study Title | A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals |
| Goal | HIV treatment using Long-Acting injectable ART will be a more successful therapy compared to a Standard of Care oral ART regimen in keeping previously non-adherent, HIV-infected individuals on treatment and virologically suppressed. |
| Who is eligible to participate | Men and women living with HIV ≥ 18 years of age. HIV RNA > 200 copies/mL, non-adherent to HIV medication. |
| Medication | Oral and Long-Acting injectable Cabotegravir and Rilpivirine |
| Duration | Up to 3.5 years |
A5377
| Study Title | A Phase I, First-in-Human, Ascending Dose Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants with HIV |
| Goal | To evaluate the safety and tolerability of SAR441236, as well as assess its ability to reduce the amount of HIV in someone's blood. |
| Who is eligible to participate | Men and Women Living with HIV, are 18-70 years old, and have never taken anti-HIV medication, including PrEP. |
| Medication | Participants will all receive infusions of open-label SAR441236. |
| Duration | 24 weeks |
| Compensation | All participants will be compensated for their time, travel and parking. |
HIV Prevention Studies
These studies are designed to investigate ways of preventing HIV acquisition.
GS-US-528-9023
| Study Title | Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection |
| Goal | To evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) infection relative to the background HIV incidence rate. |
| Who is eligible to participate | HIV negative men and transgender women, Transgender Men, and Gender Non-binary People ≥ 16 years of age, and who are determined to be at higher risk for acquiring HIV |
| Medication | Subcutaneous Lenacapavir 600 mg Twice Yearly |
| Duration | Up to 78 weeks |
| Compensation | All participants will be compensated for their time, travel & parking. |
Other Studies
DMID 21-0018
STD Vaccine Development Research Study| Goal | To determine whether FDA-approved Meningitis B vaccine, Bexsero™, will provide protection against Gonorrhea infections. |
| Who is Eligible to Participate | Participants assigned male sex at birth, between the ages of 18 and 35 years old, and are otherwise generally healthy. Due to the nature of the study, we are recommending participants who reside in a close vicinity to UNC Chapel Hill. |
| Study Procedures | • Research study lasting up to 7 months • All outpatient visits in a research clinic at UNC Chapel Hill • Receipt of FDA-approved vaccine & controlled challenge with bacteria to test protection • Involves safety phone calls & routine visits with clinical research staff |
| Duration | Up to 7 months |
| Compensation | All participants will be compensated for their time and parking. |
IMMUNE
| Study Title | Pathogenesis of Neuroinflammation and Neurocognitive Impairment in HIV-infected Young Adult Cannabis Users |
| Goal | To determine the impact of marijuana use on inflammation and thinking. |
| Who is Eligible to Participate | Men and Women living with HIV, between the ages of 18-30 years old, whom either use or do not use marijuana and are otherwise generally healthy. |
| Study Procedures | The study consists of 2 parts: Part 1 - visit at UNC or Duke that includes a peripheral blood draw, questionnaires & Neurocognitive Performance (NP) testing. Part 2 (Optional) - Lumbar puncture (at Duke) & MRI (at UNC). |
| Duration | Visit 1.0 is the only required commitment to the study which will last between 3-4 hours. If the participant is eligible and would like to participate in part 2.0 of the study, they will have up to 3 months after visit 1.0 to complete the two visits that comprise of part 2. |
| Compensation | All participants will be compensated for their time and parking. |
COVID-19 Therapeutics
The University of North Carolina at Chapel Hill is actively working to find safe and effective ways to prevent and treat COVID-19. Without you we will not find a vaccine or cure, thank you for considering taking part in such important work.
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We have two different kinds of studies:
Treatment Studies
These are studies that involve taking either a FDA-approved medication for something other than its intended purpose OR an investigational medication to safely and effectively treat a given illness or condition.
These studies typically involve:
These studies typically involve:
- Taking a medication at different time points
- Having your blood drawn to monitor safety & your body’s response to the medication
- Frequent check-ins with a clinician
A5407
Coming Soon| Study Title | A phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 |
| Goal | To determine if S-217622 will reduce the severity and length of COVID-19 related symptoms, as well as reduce the amount of associated COVID-19 associated hospitalizations |
| Who is eligible to participate | Men and Women greater than 18 years old (inclusive) with active COVID-19 |
| Medication | Oral antiviral S-217622 |
| Duration | 6 months |
| Compensation | All participants will be compensated for their time and parking |
Observational Studies
These kinds of studies DO NOT involve any sort of intervention (i.e. medication, investigational device, etc.) but rather utilize in-person or remote visits, and sample collection to gather information about a topic of interest.
These studies typically involve:
These studies typically involve:
- Surveys (either in-person or online)
- Sample collection (i.e. blood draws, nasal swabs, etc.)
The VISION Study
Coming Soon| Study Title | The Vital Status and Outcomes of COVID-19 Patients Study: The VISION Study |
| Study Goal | This is an observational study gathering data on various elements of COVID-19, such as vaccine status, prior SARS-CoV-2 infection, demographics, co-morbidities, and how these all relate to infection, symptom severity and duration, and much more. |
| Study Procedures | This will be an observational study, meaning there is no study medication or intervention, rather participants will be asked to complete surveys and collect various specimen. |
HIV CURE-related Studies
A5364
Coming Soon| Study Title | Phase I, open-label study of the safety and ability of broadly neutralizing antibodies 3BNC117-LS and 10-1074-LS in combination to durably prevent viral relapse during a monitored analytical treatment interruption |
| Goal | 1) To determine if IV infusions of 3BNC117-LS and 10-1074-LS are safe 2) To evaluate whether the combination of 3BNC117-LS and 10-1074-LS is effective in preventing the return of HIV-1 viremia for 6 months after participants stop their ART medication |
| Who is eligible to participate | HIV+ men and women between 18 and 70 years of age (inclusive), with viral suppression on ART and CD4 count greater than or equal to 450 cells/mm³ for at least 1 year prior |
| Medication | Single infusion of 3BNC117-LS & a single infusion of 10-1074-LS |
| Duration | 1.5 years |
| Compensation | All participants will be compensated for their time, travel & parking |
HIV Treatment Studies
A5415
Coming Soon| Study Title | A limited-center, prospective, double-blind, placebo-controlled study to evaluate the effects of Cenicriviroc Mesylate on arterial inflammation in people living with HIV |
| Goal | To determine whether CVC treatment results in reduced arterial inflammation |
| Who is eligible to participate | Women and men living with HIV, greater than or equal to 45 years old, HIV viral suppression for at least the past year, and with an increased cardiovascular risk |
| Medication | Cenicriviroc Mesylate (CVC) |
| Duration | 6 months |
| Compensation | All participants will be compensated for their time & parking |
COVID-19 Studies
The VISION Study
Coming Soon| Study Title | The Vital Status and Outcomes of COVID-19 Patients Study: The VISION Study |
| Study Goal | This is an observational study gathering data on various elements of COVID-19, such as vaccine status, prior SARS-CoV-2 infection, demographics, co-morbidities, and how these all relate to infection, symptom severity and duration, and much more. |
| Study Procedures | This will be an observational study, meaning there is no study medication or intervention, rather participants will be asked to complete surveys and collect various specimen. |
A5407
Coming Soon| Study Title | A phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 |
| Goal | To determine if S-217622 will reduce the severity and length of COVID-19 related symptoms, as well as reduce the amount of associated COVID-19 associated hospitalizations |
| Who is eligible to participate | Men and Women greater than 18 years old (inclusive) with active COVID-19 |
| Medication | Oral antiviral S-217622 |
| Duration | 6 months |
| Compensation | All participants will be compensated for their time and parking |