STUDY BASICS
Are you 18 to 60 years old and living with HIV? You may be eligible for a research study to test an experimental HIV vaccine combined with an experimental adjuvant to see how the immune responses change among participants who do an antiretroviral analytical treatment interruption (ATI) compared to those who do not. Compensation is provided.
STUDY PURPOSE
The purpose of this study is to understand the following:
- Are the study products safe to use in people living with HIV, and can people take the study products without being too uncomfortable.
- How do people’s immune systems respond to the study products.
- How does the immune responses to the vaccine differ in people who are using HIV medicine and in people who stop taking HIV medicine in a carefully monitored analytical treatment interruption (ATI).
- Do people living with HIV make a special kind of immune response that is important for preventing HIV, and could that guide HIV vaccine development.
COULD THIS STUDY BE RIGHT FOR YOU?
- Ages 18-60 years old
- HIV positive
WHAT PARTICIPANTS CAN EXPECT
- Screening involves a physical exam and asking about your health history.
- This trial includes 2 doses of the experimental vaccine administered 12 weeks apart while participants remain on ART, followed by an Analytical Treatment Interruption (ATI) in one group and not ATI in the control group. Participants will self-select the group in which they wish to participate due to the difference in the study visit schedules.
- You will come to the clinic for scheduled visits for about a year and 2 months. The number of visits will depend on the group you are in. Most study visits will last about 1-2 hours.
IRB: SSU00226600
- National Institutes of Health - HVTN 807, 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + Alum immunization in combination with an antiretroviral analytical treatment interruption (ATI) in people living with HIV for elicitation of VRC01-lineage antibodies (Pro00072504)MEET THE RESEARCHERS
Madhu Choudhary
Madhu Choudhary is an Associate Professor in the Division of Infectious Diseases in the Department of Medicine at the University of Pittsburgh. A graduate of Maulana Azad Medical College, Dr. Choudhary’s research interests include HIV and viral hepatitis therapeutic clinical trials.
Sharon Riddler
Sharon A. Riddler, MD, is Director of Clinical Research in the Division of Infectious Diseases at the University of Pittsburgh. A graduate of the Medical College of Wisconsin and the University of Pittsburgh, Dr. Riddler’s research interests include all aspects of the clinical research process, including protocol development, implementation, and analysis of results.