PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Background:
HIV affects millions of people. The disease may "hide" in the brain, even in people with
well-controlled HIV without cancer. Then it may "wake up" and continue. The drug
pembrolizumab uses the body s immune system to fight cells like cancer cells. It is approved
to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive
people without cancer. This study is not for HIV treatment; only one dose of the drug will be
used.
Objective:
To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive
people.
Eligibility:
Adults ages 18 and older with HIV who are in another NIH protocol
Design:
Participants will be screened with:
- Medical history
- Physical and neurological exams
- Blood tests
- Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between
back bones.
- FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter)
inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the
scanner. A mask will hold the head still.
- Leukapheresis. An optional procedure at baseline. White blood cells are removed from you
using a serum cell separator machine
Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of
contraception.
Participants will have up to 7 more visits, which repeat some screening tests.
At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They
will get allergy and pain medicines.
At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter.
They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs
for loud sounds.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)