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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.

A5321

Study TitleDecay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study
GoalGroups 1, 2, 3: Characterize patterns of HIV-1 reservoir decay and persistence within and across distinct groups of prospectively enrolled participants on suppressive ART. *Groups 1 & 3 Closed to Enrollment*
Group 4: Compare viral reservoir characteristics and immune activation/inflammation in HIV PTCs compared to suppressed individuals.
Group 5: Determine the frequency, origin, and replication competence of persistent, non-suppressible viremia in participating receiving ART.
Who is eligible to participateHIV+, > 18 years of age who meet the following group-specific criteria:
Group 2: ART started within 45 days after acute HIV-1 infection (AHI) diagnosis, on combination ART for > 1 year
Group 4: Those who have maintained virologic suppression after discontinuing ART for > 6 months
Group 5: Those with persistent low-level viremia while on ART for > 1 year
INTBlood and hair sample collections every 24 weeks for immunologic, virologic, and pharmacologic evaluations. (Optional) A single lumbar puncture for the collection of cerebrospinal fluid (CSF) to evaluate HIV-1 reservoirs and antiretroviral drug levels.
DurationUp to 6.5 years
CompensationAll participants will be compensated for their time, travel and parking.

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.

Unfortunately, we do not currently have any investigational HIV CURE studies open to enrollment, although we anticipate some will open in the near future. Please check back soon!

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.

Leuk Study

Study TitleCID 0819 - Apheresis Procedures to Obtain Leukocytes for Research Studies from HIV positive subjects
GoalTo investigate new methods of activating resting HIV infected cells in the laboratory.
Who is eligible to participateHIV + individuals > 18 years of age; VL 300; on ART > 6 months
ProcedureLeukapheresis
Duration2 visits (screening and leukapheresis). Duration is up to 3 years
CompensationAll participants will be compensated for their time, travel and parking.

A5321

Study TitleDecay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study
GoalGroups 1, 2, 3: Characterize patterns of HIV-1 reservoir decay and persistence within and across distinct groups of prospectively enrolled participants on suppressive ART. *Groups 1 & 3 Closed to Enrollment*
Group 4: Compare viral reservoir characteristics and immune activation/inflammation in HIV PTCs compared to suppressed individuals.
Group 5: Determine the frequency, origin, and replication competence of persistent, non-suppressible viremia in participating receiving ART.
Who is eligible to participateHIV+, > 18 years of age who meet the following group-specific criteria:
Group 2: ART started within 45 days after acute HIV-1 infection (AHI) diagnosis, on combination ART for > 1 year
Group 4: Those who have maintained virologic suppression after discontinuing ART for > 6 months
Group 5: Those with persistent low-level viremia while on ART for > 1 year
INTBlood and hair sample collections every 24 weeks for immunologic, virologic, and pharmacologic evaluations. (Optional) A single lumbar puncture for the collection of cerebrospinal fluid (CSF) to evaluate HIV-1 reservoirs and antiretroviral drug levels.
DurationUp to 6.5 years
CompensationAll participants will be compensated for their time, travel and parking.
HIV Treatment & Overall Health Studies

These particular studies are focused towards individuals who have been diagnosed with HIV, have been on Antiretroviral medication (ART) for at least one year, and who have undetectable viral loads . 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 TitleDoravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)
GoalThe Do-IT (A5391) research study is exploring whether people living with HIV who had >10% weight gain after starting ART that included 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 fro the treatment of HIV.
Who is eligible to participateMen and Women living with HIV, greater than 18 years old, and currently on an Integrase Inhibitor containing regimen (i.e. Biktarvy, Descovy, Tivicay, Isentress). We are looking for participants who have experiences >10% weight gain in the 1-3 years after starting these medications, have a body mass index (BMI) >27.5 kg/m2, and not planning to undergo weight loss surgery or to start significant changes to your diet or exercise habits.
MedicationParticipants will be randomized to either begin a new ARV regimen including Doravirine OR stay on their current regimen.
DurationApproximately 1 year
CompensationAll participants will be compensated for their time, travel and parking.

A5386

Study TitleA 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
GoalEvaluate 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 participateMen 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.
Medication8 Injections of an IL-15 superagonist, N-803, and potentially 2 infusions of bNAbs, 10-1074 & VRC07-523LS.
DurationUp to 112 weeks (close to 2.5 years)
CompensationAll participants will be compensated for their time, travel and parking.

A5355

Study TitlePhase 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
GoalThe 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 participateMen 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.
MedicationRandomized 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.
DurationAbout 2 years
CompensationAll participants will be compensated for their time, travel and parking.

Treatment Naive Studies

These studies are designed for individuals who have been diagnosed with HIV but have not begun taking antiretroviral medication (ART).

A5377

Study TitleA Phase I, First-in-Human, Ascending Dose Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants with HIV
GoalTo 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 participateMen and Women Living with HIV, are 18-70 years old, and have never taken anti-HIV medication, including PrEP.
MedicationParticipants will all receive infusions of open-label SAR441236.
Duration24 weeks
CompensationAll 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

Currently on Hold
Study TitleLong-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
GoalTo 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 participateHIV 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
MedicationSubcutaneous Lenacapavir 600 mg Twice Yearly
DurationUp to 78 weeks
CompensationAll participants will be compensated for their time, travel & parking.
Hepatitis, HSV & Other Studies

DMID 21-0018

STD Vaccine Development Research Study
GoalTo determine whether FDA-approved Meningitis B vaccine, Bexsero™, will provide protection against Gonorrhea infections.
Who is Eligible to ParticipateParticipants 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
DurationUp to 7 months
CompensationAll participants will be compensated for their time and parking.

A5379

Study TitleB-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): A Randomized, Controlled Trial of HEPLISAV-B vs. Engerix-B
GoalIn 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 participateMen 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.
MedicationHEPLISAV-B Vaccine – either 2 or 3 doses. Engerix-B - 3 doses
Duration72 weeks
CompensationVisits - $50. Travel & parking compensation are offered as well.

A5380

Study TitleA Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
GoalTo reduce the length of time to treat Acute HCV from 8 weeks to 4 weeks with Glecaprevir/Pibrentasivir.
Who is eligible to participateMen and Women 18 years or older who have been infected with HCV within the past 6 months. Participants who are living with or without HIV are eligible.
MedicationGlecaprevir/Pibrentasvir (G/P) will be given for 4 weeks. Participants who fail the initial treatment will be treated on the study with G/P with or without ribavirin.
Duration28 weeks
CompensationAll participants will be compensated for their time, travel and parking.

IMMUNE

Study TitlePathogenesis of Neuroinflammation and Neurocognitive Impairment in HIV-infected Young Adult Cannabis Users
GoalTo determine the impact of marijuana use on inflammation and thinking.
Who is Eligible to ParticipateMen 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 ProceduresThe 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).
DurationVisit 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.
CompensationAll participants will be compensated for their time and parking.

Acute HIV Infection

A5388 bNAbs in Acute HIV

Study TitleA Randomized Clinical Trial of Combination HIV-Specific Broadly-Neutralizing Monoclonal Antibodies
Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
GoalTo evaluate the safety of combination bNAb therapy plus antiretroviral therapy during Acute HIV infection
Who is eligible to participateAcute HIV positive individuals prior to enrollment, 18-70 years old, who are not currently pregnant or breastfeeding, and are determined and willing to participate in scheduled study visits
MedicationVRC07-523LS plus PGT121.414.LS 523LS intravenous infusion
DurationUp to 264 weeks

COVID-19 Studies

The VISION Study

Study TitleThe Vital Status and Outcomes of COVID-19 Patients Study: The VISION Study
Study GoalThis 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 ProceduresThis 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.

COVAIL

Study TitleCOVID-19 Variant Immunologic Landscape (COVAIL) Trial
Study GoalThis is a phase 2 clinical trial evaluating whether a second booster shot directed towards COVID-19 could effectively broaden someone's immunity to potential new COVID-19 variants.
Study PopulationAdults who have already received a primary vaccination series as well as a booster shot for COVID-19. We are enrolling both those who have, as well as those who have not received a positive COVID-19 diagnosis.