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
|Male and Female Patients
|U.S. Govt. ID:
|Anyelina Cantos: 212-305-7897 / email@example.com
The purpose of this study is to look at whether these study drugs improve the bodys response to human immunodeficiency virus (HIV) in people with HIV (PWH) who started antiretroviral therapy (ART) early after getting HIV-1. The study treatments we are investigating are a study treatment vaccine, a study 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 US FDA except to be used in this research study. For study entry, 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 products. 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, and if you do not need to restart ART, you will go into Part 4. The study will enroll 45 participants in total, 30 of whom will receive active study treatment and 15 of whom will receive placebo. You will be eligible if you are a person who started HIV treatment soon after you got HIV, have been on stable ART for at least 1 year prior to study entry, have a CD4 count of at least 500 cells/mm3, have an HIV viral load that is undetectable, and are willing to undergo a supervised HIV treatment interruption during the study. This means that you will stop your ART and have frequent study visits for a period of time. Participation in this study will last up to 110 weeks (about 2 years and 3 months). The following study procedures will take place: physical exams, 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.
Magdalena Sobieszczyk, MD
|Did you start HIV treatment soon after you were diagnosed with HIV?
|Have you been on ART (antiretroviral therapy) for at least one year?