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NCT03367754 · ClinicalTrials.gov registry record · Phase 1
A Single Dose of Pembrolizumab in HIV-Infected People
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03367754: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03367754 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03367754, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study 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 medicines 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.
Primary Outcome
Participants with either grade 2 or higher autoimmune events requiring corticosteroid therapy or grade 3 or higher adverse events that are possibly, probably, or definitely related to intervention. The severity of each adverse event was graded according to the "Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events". Grade 2: Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDS, narcotics, IV
Interventions
- DRUG Pembrolizumab
- OTHER Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-08-06 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 1 |
Why NCT03367754 stopped before completion
NCT03367754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03367754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03367754 about?
NCT03367754 is a clinical study titled "A Single Dose of Pembrolizumab in HIV-Infected People". 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 i...
What is the current status of trial NCT03367754?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-08-06. Estimated completion is 2024-11-18.
What interventions are being tested in trial NCT03367754?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (OTHER).
Who is sponsoring clinical trial NCT03367754?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03367754's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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