Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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. ...
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06819176
The ClinicalTrials.gov registry entry for NCT06819176 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (73% 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 Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which Lenacapavir is the first listed.
NCT06819176 reports 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Human Immunodeficiency Virus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)
ACTIVE NOT RECRUITING · Phase 1
-
First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS
COMPLETED · Phase 1
-
Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)
COMPLETED · Phase 1
-
Evaluation of the Safety of a Polyvalent Virus in Healthy Adults
COMPLETED · Phase 1
-
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
COMPLETED · Phase 1
-
First in Human Study of TLC-ART 101 (ACTU 2001)
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.