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NCT06819176 · ClinicalTrials.gov registry record · Phase 1
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
A Phase 1 study of Human Immunodeficiency Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06819176: Recruiting Phase 1 study of Human Immunodeficiency Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06819176 is a Phase 1 study of Human Immunodeficiency Virus that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06819176, a Phase 1 study of Human Immunodeficiency Virus, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART. Objective: To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART. Eligibility: People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART. Design: Participants will have 13 clinic visits over 2 years. Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study. Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube. Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study. ...
Primary Outcome
To compare the effect of the presence or absence of lenacapavir on intact HIV proviral DNA reservoirs in PWH who had been receiving virologically suppressive (\<40 copies/mL) ART for greater than 3 years.
Conditions Studied
Interventions
- DRUG Lenacapavir
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2029-01-24 |
| Phase | Phase 1 |
What NCT06819176 shows while recruiting
NCT06819176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which Lenacapavir is the first listed.
NCT06819176 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06819176 about?
NCT06819176 is a clinical study titled "Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy". Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood....
What is the current status of trial NCT06819176?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2026-01-20. Estimated completion is 2029-01-24.
What conditions does trial NCT06819176 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus.
What interventions are being tested in trial NCT06819176?
The interventions under investigation include: Lenacapavir (DRUG).
Who is sponsoring clinical trial NCT06819176?
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 NCT06819176 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06819176's enrollment target sits among peer trials
50 24th of 39 higher than 16 of 39 other Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus 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.
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