Effectiveness of Combining Broadly Neutralizing Monoclonal Antibodies with Standard ART for People with Acute HIV Infection
This study is looking at whether a type of special antibody called broadly neutralizing antibodies (bNAbs) is safe to use along with antiretroviral therapy (ART) in people who have been recently diagnosed with HIV. We also want to find out if these antibodies help control HIV better after people stop their regular medicine (ART), compared to those who didn’t get the antibodies.
Why this Research Matters
Scientists are trying to find ways to lower the amount of HIV in the body. Starting HIV treatment (called ART) right after someone is diagnosed can help keep their immune system strong. Giving special antibodies (called bNAbs) along with ART might help stop HIV from spreading.
What to Expect
If you join this study, you will be randomly placed into one of two groups- like flipping a coin. You will not know which group you are in. Everyone will take ART every day at the start of the study and maybe again at the end. One group will get a single dose of two special antibodies (called bNAbs). The other group will get a placebo, which looks like the same but does not have any real medicine. At most visits, your blood will be taken from a vein in your arm. You will get a physical exam at most visits and give a urine sample at some visits. You might also have a procedure called leukapheresis, which collects white blood cells. For this, blood is collected from a vein in one arm, goes through a machine, and then is returned through the vein in your other arm. This takes about 1 to 4 hours. You will be in the first part of the study for about 1 year and come in for 8 visits. After that, you will stop ART for up to 2.5 years. During this time, you will have a study visit every 8 weeks, then every 2 weeks for up to 4 months until you show signs that you need to start ART again. Once you restart ART, you will have 6 more study visits over the next year. Altogether, you may have up to 59 study visits over 5 years. You will be paid up to $3,050 if you complete all visits.
Study Duration
Altogether, you may have up to 59 study visits over 5 years.
Who can Participate
You can join this study if you are between 18 and 70 years old and were recently diagnosed with HIV-1. You must be willing to take special antibodies (called bNAbs) and start HIV treatment.
You can't join this study if you have taken HIV prevention medication (pre-exposure ART or PrEP) in the past 60 days, if you have hepatitis B or C, or have serious heart problems.
Study ID
Protocol Number: 23-0252
More information available at ClinicalTrials.gov: NCT05719441
Compensation Information
Meet the Team
Principal Investigator