A5374: A Phase I/IIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen with Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy during Acute HIV-1
Sponsor: |
NIH |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU5111 |
U.S. Govt. ID: |
NCT04364035 |
Contact: |
Max Flanagan: 212-305-7897 / mhf2142@cumc.columbia.edu |
The main purpose of this study is to look at whether experimental study drugs are safe, whether your body can handle the effects, and whether these study drugs improve the body's response to human immunodeficiency virus (HIV) in people with HIV (PWH) who started antiretroviral therapy (ART) early after getting HIV-1. The study treatments include: a treatment vaccine (not a preventative vaccine), a drug called vesatolimod (VES), and two broadly neutralizing antibodies (bNAbs; antibodies are natural proteins that the body makes in response to an infection), called GS-5423 and GS-2872. None of these experimental products has been approved by the United States Food and Drug Administration (FDA) except to be used in this research study. Each of these experimental treatments has been studied in small numbers of people, but they have not been given together. The study will take place in 4 parts. At study entry (Part 1), you will be randomized (like rolling the dice) in a 2 to 1 ratio to receive either the active experimental products (study vaccines, VES, and bNAbs) or placebo. In Part 2, you will stop taking ART and there will be no experimental products provided. After Part 2, if you need to restart ART, you will go into Part 3; if you don't need to restart ART, you will go into Part 4. Participation in this study will last up to 110 weeks (about 2 years and 3 months). The actual length of time you are on this study will depend on how long you remain off ART. Participating in this study may prevent you from participating in another study of an immunologic intervention for a period of time. If you are part of the study, the following study procedures will take place: physical exams including vital signs, recording your symptoms in a diary log, completing health-related questionnaires, providing blood and urine samples and receiving study product or placebo including vaccinations, oral tablets and IV infusions. Compensation will be provided for your time and participation.
Investigator
Magdalena Sobieszczyk, MD
Did you start HIV treatment soon after you were diagnosed with HIV? |
Yes |
No |
Have you been on ART (antiretroviral therapy) for at least one year? |
Yes |
No |