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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.

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

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.

XTRA

Study TitleIGHID 11627 - A Phase I Study to Evaluate the Effects of Vorinostat and HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) on Persistent HIV-1 Infection in HIV-Infected Individuals Started on Antiretroviral Therapy
GoalTo test the safety of HIV T cell therapy + VOR (Vorinostat), as well as gauge its impact on the latent HIV reservoir.
Who is eligible to participateHIV positive men and women, ≥18 and < 65 years of age, with durable viral suppression as measured on standard HIV RNA assays for ≥24 months. Eligible participants must be on stable combination ART (cART) and have a CD4 count ≥350 cells/mm3.
MedicationVorinostat and Expanded Specific T-Cell Therapy
DurationUp to 48 months
CompensationAll participants will be compensated for their time, travel and parking.

The M&M Study

Study TitleIGHID 11810 - A Phase I Pilot Study to Evaluate the Safety and Immunogenicity of the HIV-1 Vaccines MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) Given Alone or In Combination in HIV-1-Infected Adults Suppressed on Antiretroviral Therapy – The M&M Study.
GoalSafety and ability of 2 different HIV vaccines to provoke an immune response to kill the HIV virus within the body.
Who is eligible to participateHIV positive men and women 18-65 years of age. CD4 ≥ 350, HIV RNA < 50 for 2 years.
Medication2 HIV vaccines: MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4)
Duration8 months
CompensationAll participants will be compensated for their time, travel and 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.

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.

HIV Reservoir in Women

Study TitleThe HIV Reservoir in Women: Implication for HIV Cure Strategies
GoalTo characterize HIV reservoir size, stability, and persistence in women as well as evaluate approaches to disrupt HIV latency in women.
Who is eligible to participateHIV-1 positive women, ≥18 and ≤ 62 years of age, on stable cART with HIV-1 RNA levels < 50 copies/mL for at least 12 months, as measured on standard HIV RNA assays. Eligible participants must have a CD4 cell count ≥ 300
ProcedureLeukapheresis procedure and optional sigmoidoscopy procedure
DurationUp to 3 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.

GS-US-536-5816

Coming Soon
Study TitleA Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination with Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults with HIV-1 Infection
GoalTo Determine how safe and effective an infusion every 6 months of 2 bNAbs & a HIV capsid inhibitor are in comparison to the standard once a day oral ART
Who is eligible to participateMen and Women living with HIV between 18 and 65 years old. Eligible participants must have been on ART for at least two years at the time of screening and plasma HIV <50 copies/mL for 18 months prior to the screening visit.
Medication2 infusions of a combination of two bNAbs (GS-5423 & GS-2872) with a HIV capsid inhibitor, Lenacapavir (GS-6207)
DurationApproximately 52 weeks (1 year)
CompensationAll participants will be compensated for their time, travel & parking.

Treatment Naive Studies

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

 

HIV Prevention Studies

These studies are designed to investigate ways of preventing HIV acquisition.

MK 022

Study TitleEvaluation of the efficacy and safety of oral Islatravir as a pre-exposure prophylaxis in cisgender women at high risk for HIV-1 Infection
GoalTo evaluate how effective oral Islatravir is at preventing HIV infections in women who are at higher risk of HIV acquisition
Who is eligible to participateHIV negative women, 18-45 years old, who are not currently pregnant or breastfeeding, and are determined to be at higher risk for acquiring HIV
MedicationOral Islatravir 60mg once monthly
DurationUp to 3 years

MK 024

Study TitleEvaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as pre-exposure prophylaxis in cisgender men and transgender women who have sex with men and are at high risk for HIV-1
GoalTo evaluate how effective oral Islatravir is at preventing HIV infections in men and transgender women who are at higher risk of HIV acquisition
Who is eligible to participate HIV negative men and transgender women, 18-45 years old, and who are determined to be at higher risk for acquiring HIV
MedicationOral Islatravir 60mg once monthly
DurationUp to 4 years

GS-US-528-9023

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

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.

HIV CURE-related Studies

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.

HIV Treatment & Overall Health Studies

GS-US-536-5816

Coming Soon
Study TitleA Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination with Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults with HIV-1 Infection
GoalTo Determine how safe and effective an infusion every 6 months of 2 bNAbs & a HIV capsid inhibitor are in comparison to the standard once a day oral ART
Who is eligible to participateMen and Women living with HIV between 18 and 65 years old. Eligible participants must have been on ART for at least two years at the time of screening and plasma HIV <50 copies/mL for 18 months prior to the screening visit.
Medication2 infusions of a combination of two bNAbs (GS-5423 & GS-2872) with a HIV capsid inhibitor, Lenacapavir (GS-6207)
DurationApproximately 52 weeks (1 year)
CompensationAll participants will be compensated for their time, travel & parking.

Other Studies

A5368

Study TitleSafety and Immunotherapeutic Activity of Cemiplimab in Participants with HBV on Suppressive Antiviral Therapy: A Phase I/II Ascending Multiple Dose Study
GoalThis study is trying to find out if cemiplimab is safe and well tolerated. Participants will receive multiple doe levels (0.3, 1.0, and 3.0 mg/kg) of cemiplimab administered as two infusions at weeks 6 and 12.
Who is eligible to participateMen and Women 18 to 70 years old, living with chronic hepatitis B infection.
MedicationMultiple dose levels (0.3, 1.0, 3.0 mg/kg) of cemiplimab administered as two infusions.
DurationApprox. 2 years
CompensationVisits - $50. Travel & parking compensation are offered as well.

HPTN 092

Coming Soon
Study TitleA phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous infusion or via subcutaneous injections in healthy, HIV-uninfected adult participants
GoalWe are interested in evaluating a new HIV antibody called PGT121.414.LS, alone and in combination with a previously studied antibody, VRC07-523LS, that may be used in the future to prevent HIV infections.
Who is eligible to participateMen and women between 18 and 50 years old. Generally healthy.
MedicationEither IV infusions or subcutaneous injections of monoclonal antibody PGT121.414.LS alone or in combination with VRC07-523LS
DurationStudy participation length varies between 6-16 months
CompensationAll participants will be compensated for their time, travel & parking.