A Single Dose of Pembrolizumab in HIV-Infected People
Status:
Recruiting
Trial end date:
2022-11-20
Target enrollment:
Participant gender:
Summary
Background:
Human immunodeficiency virus (HIV) attacks the immune system. Some people with HIV have a low
CD4+ T-cell count despite taking antiviral medicines that control HIV replication. These
cells fight disease, so a low count makes it easier for people to become sick. Researchers
want to see if a new drug can improve the immune system, including T cells. The drug is
called pembrolizumab
Objective:
To see if pembrolizumab is safe to use in people with HIV who have a low CD4+ T cell count
despite taking medcines that control HIV replication, and to see if it strengthens the immune
system.
Eligibility:
People age 18 years or older with HIV who are taking antiretroviral drugs as treatment, have
blood HIV levels below detection limits of commercial assays, and have a low CD4+ T-cell
count (below 350 cells/mm3).
Design:
Participants will be screened with:
Medical history
Physical exam
Heart, blood, and urine tests
Sexually active participants must use 2 kinds of birth control.
Participants will have leukapheresis. Blood will be removed through a needle in one arm. A
machine will remove white blood cells. The rest of the blood will be returned into the other
arm.
Participants will have a baseline visit. They will have blood tests. They may have a
pregnancy test.
A needle will insert a thin plastic tube (IV) into an arm vein. The participants will get the
study drug or a placebo through the IV for 30 minutes. They will be watched for a couple
hours after.
Participants will have 11 follow-up visits over the next 48 weeks. They will have a physical
exam, vital signs, medical review, and blood tests.
Participants may have another leukapheresis.
Participants will be called every 12 weeks after their last follow-up visit to talk about how
they feel and their health. Participation ends after the week 96 phone call.
...
Phase:
Phase 1
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)