HIV Research Study
Researchers at Beth Israel Deaconess Medical Center are conducting a study in individuals living with HIV to evaluate an investigational treatment with two different types of vaccination.
Fast Facts
Diagnosed With HIV
18-65 Years Old
Conducted in Boston, MA
Compensation Provided
Study Background
This trial studies the safety, tolerability, and ability of two investigational products (not FDA licensed), HB-502 and HB-501, to stimulate an immune response against HIV in people living with HIV.
The primary treatment for HIV is called antiretroviral therapy (ART). Although ART has represented a huge step forward in treating HIV, the benefits of available ART are short-lived. After a period of initial improvement, eventually there is a return of rapid HIV replication and higher viral copy number.
In this research study, we will test the safety and effectiveness of adding an alternating 2-vector therapy (meaning that two different types of modified viruses are used to deliver the treatment directly to your cells) to people who are already taking ART. The study treatment is investigational and designed to train the body to recognize and fight parts from substances found in HIV.
Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks, which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment. We hope that eventually, the findings of this study might be useful for better treating HIV.
Study Background
This trial studies the safety, tolerability, and ability of two investigational products (not FDA licensed), HB-502 and HB-501, to stimulate an immune response against HIV in people living with HIV.
The primary treatment for HIV is called antiretroviral therapy (ART). Although ART has represented a huge step forward in treating HIV, the benefits of available ART are short-lived. After a period of initial improvement, eventually there is a return of rapid HIV replication and higher viral copy number.
In this research study, we will test the safety and effectiveness of adding an alternating 2-vector therapy (meaning that two different types of modified viruses are used to deliver the treatment directly to your cells) to people who are already taking ART. The study treatment is investigational and designed to train the body to recognize and fight parts from substances found in HIV.
Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks, which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment. We hope that eventually, the findings of this study might be useful for better treating HIV.
Additional Information
This research study will examine the safety, tolerability, and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV.
You may qualify for the study if you meet the following criteria.
Inclusion Criteria:
- Ages 18-65
- Diagnosed with HIV
- On stable dose of ART for at least 48 weeks
- Body mass index (BMI) ≤ 40
Exclusion Criteria:
- HIV-associated malignancy (including Kaposi’s sarcoma) or any type of lymphoma or virus-associated cancers
- > stage 2 HIV-related illness
- History of HIV-associated neurocognitive disease
- History of chemotherapy in the past 3 years
- Known history of hepatitis B virus (HBV) or active hepatitis C virus (HCV)
- Active, untreated TB disease
- Diabetes diagnosis
The entire study lasts 48 weeks. Once enrolled, the study involves:
- 16 in-person visits
- Medical and medication history collection
- Physical exams with vital signs, height, weight, ECG, pregnancy and contraception counseling
- 4 vaccinations over 24 weeks
- Blood, urine, saliva, and stool sample collection (stool swabs can be collected at home)
As a participant, you can receive up to $75 per study visit and a parking voucher for each visit.
There is no cost for you to participate in our research study.
Meet The Principal Investigator
Ai-ris Yonekura Collier, M.D
Beth Israel Deaconess Medical Center
Dr. Ai-ris Yonekura Collier is a physician-scientist specializing in high-risk pregnancy care in the Department of Obstetrics and Gynecology at BIDMC. Dr. Collier obtained her M.D through the Harvard-MIT Program in Health Sciences and Technology at Harvard Medical School where she spent time in the lab of Dr. Shannon Turley, evaluating a novel mechanism of cellular immune tolerance induction by lymph node stroma cells. The goal of her translational research is to characterize the maternal cellular immune phenotype in pregnancy disorders like preeclampsia and fetal growth restriction, as well as in the setting of infectious disease like Zika virus or SARS-CoV-2. As a Maternal-Fetal Medicine clinician, she represents a cross-disciplinary collaboration between the Department of Obstetrics and Gynecology and the Center for Virology and Vaccine Research.
