Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy

Recruiting now · Phase 1

Conditions studied: Human Immunodeficiency Virus

In brief

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. ...

Key facts

Study ID

NCT06819176

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Starts

2026-01-20

Expected to finish

2029-01-24

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• History of AIDS-defining illness within 3 years prior to enrollment.
• History of systemic corticosteroids (eg, an equivalent dose of prednisone of >20 mg daily for >14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the principal investigator within the last 6 months.
• Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation.
• Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus (HCV) RNA in blood.
• NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
• Pregnancy or lactation.
• Any licensed vaccine (eg, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to the study enrollment.
• Receipt of other investigational study agents within 28 days of enrollment and at any time during the study, including any experimental non-HIV vaccination within 2 weeks prior to enrollment.
• Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded:
• Corticosteroid nasal spray or inhaler.
• Topical corticosteroids for mild, uncomplicated dermatitis.
• Oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy 10 days, with completion in 30 days prior to enrollment).
• Cyclosporine eye drops
• Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Laboratory abnormalities in the parameters listed below:
• Absolute neutrophil count <1,000 cells/mm\^3
• Hemoglobin <10 g/dL
• Platelet count <100,000 cells/mm\^3
• ALT >1.5 x ULN
• AST >1.5 x ULN
• Total bilirubin >1.5 x ULN
• Estimated glomerular filtration rate <30 mL/min/1.73m\^2
• Inability to undergo leukapheresis due to poor venous access or other medical conditions.
• Concurrent treatment with any of the medications listed below:

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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