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NCT05612178 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy
A Phase 1 study of HIV-1, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
- 2
- Study locations
NCT05612178 is a Phase 1 study of HIV-1 that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 105 participants, below the 125-participant average among 9 other HIV-1 trials with a reported enrollment target (16% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05612178, a Phase 1 study of HIV-1, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Yet lifelong ART is expensive and can lead to serious side effects over the long term. Some drugs may be more effective at reducing the PVR. Objective: To see if 2 study drugs (3BNC117-LS and 10-1074-LS) are safe and if they can lower the number of HIV-infected blood cells in people with HIV who are on ART. Eligibility: People aged 18 to 70 years with HIV who are on ART. Design: Participants will be screened. They will have a physical exam and blood and urine tests. They will undergo leukapheresis. Leukapheresis is a procedure where blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. The study drugs or placebo (normal saline) will be administered 3 times at 20-week intervals. The drugs will be given through a tube attached to a needle inserted into a vein in the arm. This will take 1 hour. Some participants will receive only a saline solution. They will not know if they are getting the drugs or the placebo. Participants will undergo leukapheresis up to 4 more times during the study. Participants will have follow-up visits every 10 weeks until the study ends.
Conditions Studied
Interventions
- OTHER Sterile Saline
- BIOLOGICAL 3BNC117-LS
- BIOLOGICAL 10-1074-LS
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
New York
- The Rockefeller University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2023-07-26 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05612178
The ClinicalTrials.gov registry entry for NCT05612178 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 9 other HIV-1 trials with a reported enrollment target (16% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV-1 appearing as the primary indexed condition, and to 3 interventions - of which Sterile Saline is the first listed.
NCT05612178 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT05612178 about?
NCT05612178 is a clinical study titled "A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy". Background: Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Yet lifelong ART is expensive and...
What is the current status of trial NCT05612178?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2023-07-26. Estimated completion is 2027-03-31.
What conditions does trial NCT05612178 study?
This clinical trial studies the following conditions: HIV-1.
What interventions are being tested in trial NCT05612178?
The interventions under investigation include: Sterile Saline (OTHER), 3BNC117-LS (BIOLOGICAL), 10-1074-LS (BIOLOGICAL).
Who is sponsoring clinical trial NCT05612178?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05612178 being conducted?
This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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