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NCT03571204 · ClinicalTrials.gov registry record · Phase 1
Combination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03571204: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03571204 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 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03571204, 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
- 27 participants
- Enrollment target
Study Summary
Background: Human immunodeficiency virus (HIV) affects the immune system. The main function of the immune system is protect you from infections and other diseases such as cancer. HIV attacks and cripples the immune system making people more susceptible to a variety of infections and cancers. Currently, the standard treatment for HIV infection is a daily administration of anti-HIV drugs. These drugs are called combination antiretroviral therapy (ART). ART is very effective at suppressing HIV, but does not cure HIV infection. ART must be taken continuously for life to be effective. ART can stop being effective if not taken correctly and can cause permanent side effects. Researchers want to see if two new products can control HIV infection without the use of ART. The products are the antibodies 3BNC117 and 10-1074. Objective: To see if 3BNC117 and 10-1074 are safe and can control HIV levels in the blood of people who are not taking ART or people who stop taking their ART during the study. . Eligibility: Adults ages 18-65 with HIV who are: * on ART and willing to stop treatment for at least 28 weeks * OR not taking ART with low levels of HIV in the blood Design: Participants will be screened with a physical exam, medical history, and blood, heart, and urine tests. Participants will get the 2 study products or salt water (placebo). A thin tube will be placed in an arm vein. Each product will be given directly into the vein for about 1 hour. To help collect blood cells to study in the laboratory, participants may have a procedure known as leukapheresis in which blood will be removed through a needle in the arm. Some of the white blood cells will be separated from the blood and used for research studies to see how 3BNC117 and 10-1074 effects HIV and the immune system. The rest of the blood will be returned to the person through another needle in the arm. Participants will have 18 study visits over 28 weeks. They will repeat some screening tests. They may have le
Primary Outcome
Participants with grade 3 or higher adverse events (AE), including serious adverse advents. AE severity was graded according to the Division of Aids Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1, July, 2017
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL 3BNC117 and 10-1074
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 1 |
Why NCT03571204 stopped before completion
NCT03571204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03571204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03571204 about?
NCT03571204 is a clinical study titled "Combination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals". Background: Human immunodeficiency virus (HIV) affects the immune system. The main function of the immune system is protect you from infections and other diseases such as cancer. HIV attacks and cripples the immune system making people more susceptible to a variety of infections and cancers. Curren...
What is the current status of trial NCT03571204?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-09-10. Estimated completion is 2021-03-29.
What interventions are being tested in trial NCT03571204?
The interventions under investigation include: Placebo (BIOLOGICAL), 3BNC117 and 10-1074 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03571204?
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 NCT03571204's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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