PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection (NCT03239899) | Clinical Trial Compass
CompletedPhase 1
PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection
United States13 participantsStarted 2018-04-09
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* 18 years or older
* Diagnosis of HIV-1 infection, with positive HIV 1 antibody testing
* HIV RNA less than or equal to 40 copies/mL in plasma in the last 12 or greater months
* CD4 count above 350 cells/uL
* Antiretroviral therapy for 12 months prior to trial
* Fully vaccinated against SARS-CoV-2. Fully vaccinated is defined as:
* Two weeks out from the second dose of a two-dose vaccine series (Moderna, Pfizer-BioNTech); or
* Two weeks out from a single-dose vaccine (Johnson \& Johnson/Janssen)
* Patient must be willing and able to comply with all the aspects of trial design and follow-up.
* Patients must be able to provide informed consent
* Women of childbearing potential must agree to use contraception (defined as two forms of effective birth control), from the time of enrollment until 4 months after the last exposure to pembrolizumab
* Participants who are physically able to father a child must agree to use 2 effective methods of contraception (birth control) from the time you enroll in the study until 4 months after your last exposure to pembrolizumab
* Effective methods of contraception for this study include:
* hormonal contraception (birth control pills, birth control patches, injected hormones, hormonal implants or vaginal ring),
* Intrauterine device,
* Barrier methods (condom or diaphragm) combined with spermicide, and
* Surgical sterilization (hysterectomy, tubal ligation, or vasectomy).
* If you have had a hyst…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Grade 3 or Higher Adverse Events
Timeframe: study duration (up to 52 weeks post infusion)
Trial details
NCT IDNCT03239899
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)