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 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.

A5354

Study TitleEffect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
GoalAnalyze the effects of starting Antiretroviral Therapy (ART) at different stages of acute HIV infection on HIV reservoirs and specific immune responses associated with HIV.
Who is eligible to participateMen and women older than 18 years of age with a diagnosis of acute HIV infection.
MedicationFDA-approved Genvoya
Duration72 weeks
CompensationVisits - $25.00, Optional procedure visits - up to $250, Total - approximately $500. Travel & parking compensation are offered as well.

PHI 05

Study TitleIGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect
GoalTo provide HIV medication as soon as possible after being diagnosed with Acute HIV infection (AHI). To evaluate the safety and virologic effectiveness of Triumeq as initial treatment for acute HIV infection.
Who is eligible to participateMen and women older than 18 years of age with a diagnosis of acute HIV infection.
MedicationTriumeq - a FDA approved one pill once a day medication. This pill contains three medications, dolutegravir 50 mg, abacavir 600 mg and lamivudine 300 mg, in a fixed dose combination.
Duration5 years (medication provided for 2 years). The first 2 years of the study requires 13 clinic visits, ranging weekly to every 3 months. The last 3 years requires 5 clinic visits in total over the 3 years.
CompensationVisits - $25.00; total approximately $325.00. Optional procedure visits - up to $400. Travel & parking compensation are offered as well.

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.

A5377

Study TitleA Phase I, First-in-Human, Ascending Dose Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants with HIV
GoalThe purpose of this study is to test the safety, tolerability, and dose finding of a drug that has not been tested in humans before now. This experimental drug is a Tri-specific antibody and is called SAR441236.
Who is eligible to participateHIV positive men and women who have either never received ART, or who have taken ART for > 12 months
MedicationSAR441236 via 1- 4 IV infusions
Duration4-18 months
CompensationVisits - $50, Infusion visits with PK - $250. Arm A, groups 1-3, Total - $800. Arm A, group 4, Total - $1,950. Arm B, all groups, Total - $850. Travel & parking compensation are offered as well.

A5370

Study TitleSafety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in HIV-1-infected Participants on Suppressive cART: A Phase I/II, Double-blind, Placebo-controlled, Ascending Multiple Dose Study
GoalThe safety of 2 doses of the monoclonal antibody, Cemiplimab, in HIV positive individuals, and its ability to improve the immune response to HIV.
Who is eligible to participateHIV positive men and women, ≥18 and < 65 years of age, with HIV suppression for ≥18 months. Eligible participants must be on stable ART and have a CD4 count ≥350 cells/mm3.
MedicationCemiplimab or placebo
Duration48 weeks
CompensationVisits - $50, Infusion visits - $150, Total - $1050. A meal will be provided at each infusion visit. Travel & parking compensation are offered as well.

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
CompensationVisits - $50, Leukapheresis procedure visits - $150 in addition to visit compensation, HXTC infusions - $150, VOR dose - $50, Total - $3700. Travel & parking compensation are offered as well.

DART

Study TitleCP-MGD014-01- A Phase I study to evaluate the safety, immunologic and virologic responses of MGD014 therapy in HIV-infected individuals on suppressive antiretroviral therapy
GoalCharacterize the safety and tolerability of MGD014 administered intravenously (IV) to HIV-infected participants maintained on suppressive ART.

Who is eligible to participateHIV positive adults (18 to 65 years old) on ART with plasma HIV RNA < 50 copies/mL for 24 months prior to enrollment.Eligible participants must be on stable combination ART (cART) and have a CD4 count ≥ 350 cells/mm3.
MedicationMGD014 administered via a single infusion in Part 1 or a weekly infusion, for 6 weeks, in Part 2
Duration10 weeks (Part 1) or 20 weeks (Part 2)
CompensationPart 1: Step 1 - $100, Step 2 - up to $750, Step 3 - $150, Total - up to $1000.

Part 2: Step 1 - $300, Step 2 - $1350, Step 3 - $400, Total - $2050.

Travel & parking compensation are offered as well.

VOR-07

Study TitleIGHID 11802 - Combination Therapy with the Novel Clearance Modality (VRC07-523LS) and the Latency Reversal Agent (Vorinostat) to Reduce the Frequency of Latent, Resting CD4+ T Cell Infection (The VOR-07 Study)
GoalTo evaluate the safety and tolerability of combination therapy with VRC07-523LS and VOR in HIV-infected participants on cART.
Who is eligible to participateHealthy men and women of any race with HIV-1 infection, ages 18 through 64, suppressed on ART therapy for > 24 months. Eligible participants must have a CD4 cell count ≥ 300 cells/mm3.
MedicationVorinostat and VRC07-523LS
Duration36 weeks
CompensationVisits - $50, Leukapheresis procedure visits - $50, Infusions - $200, VOR dose - $50, Total - $2525. Travel & parking compensation are offered as well.

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 18-45 years of age. CD4 ≥ 350, HIV RNA < 50 for 2 years.
Medication2 HIV vaccines: MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4)
Duration4 months
CompensationNon-vaccine visits - $50, Vaccine visits - $75, Fine needle Aspiration (optional) - $300, Leukapheresis procedure visits - $200, Total - $1325- $2025.

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
CompensationScreening visit - $25, Leukapheresis - $150. Travel & parking compensation are offered as well.

The Aging Study

Study TitleIGHID 11822 ‐ Age‐Associated Mitochondrial Dysfunction in CD8 T cells of HIV Infected Persons
GoalObtain blood sample to investigate how HIV serostatus and age impacts levels of mitochondrial function in CD8 T cells and CD8 memory phenotype. Secondary objective is to investigate how HIV serostatus and age impact mitochondrial function in CD8 T cells such as the generation of energy to support antigen-driven proliferation.
Who is eligible to participateHIV + & HIV – participants; >18 years of age; HIV + individuals must have VL 24 months, and CD4 >300
ProcedureBlood draws
DurationUp to 2 visits
CompensationScreening visit - $50, Blood draw visit - $100. Travel & parking compensation are offered as well.

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
CompensationVisits - $50, Leukapheresis - $200, Sigmoidscopy - $300. Travel & parking compensation are offered as well.
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.

A5359

Study TitleA Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals
GoalHIV 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 participateHIV infected men and women ≥ 18 years of age. HIV

RNA > 200 copies/mL, non-adherent to HIV medication.
MedicationOral and Long-Acting injectable Cabotegravir and Rilpivirine
DurationUp to 3.5 years
HIV Prevention Studies

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

We do not currently have any open studies that fall into this category, but please check back soon.

Hepatitis, HSV & Other Studies

A5375

Study TitleAn Open-Label, Phase II Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination with Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
GoalTo determine if a double dose of Levonorgestrel is needed to overcome drug-drug interactions in women who are taking Efavirenz-based anti-HIV medications or RIF/INH anti-TB medications, as well as safety and tolerability of double dose.
Who is eligible to participateWomen ≥18 years of age and either: HIV positive and taking Efavirenz-based ART OR Dolutegravir-based ART (control arm) OR HIV negative & in the continuation phase of TB treatment on daily RIF/INH. Eligible participants must be pre-menopausal with a uterus and both ovaries and must not currently be pregnant, within 6 weeks of delivery, or currently breastfeeding an infant under 6 months of age. Eligible participants must also agree to use an approved non-hormonal birth control method during the study.
MedicationLevonorgestrel (LNG) 1.5mg or 3mg
Duration4 weeks
Compensation$300 total ($25 at screen, day 1, day 2 and for telephone calls at weeks 1, 2 & 4. $150 for 8 hour pk at entry). Travel & parking compensation are offered as well.

HIV CURE-related Studies

We do not currently have any studies that fall into this category, but please check back soon.

HIV Treatment & Overall Health Studies

We do not currently have any studies that fall into this category, but please check back soon.

Other Studies

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
CompensationVisits - $50. Travel & parking compensation are offered as well.

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.