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NCT06819176
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
Conditions: Human Immunodeficiency Virus
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 50
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: National Institutes of Health Clinical Center Bethesda Maryland
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.
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Eligibility Criteria
* INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Able to provide informed consent.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Aged 18 years to 75 years.
4. In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study.
5. Confirmed HIV-1 infection.
6. Total HIV DNA reservoir size greater than 300 copies/106 CD4+ T cells.
7. CD4+ T cell count \>200 cells/mm\^3 at screening.
8. Documentation of continuous ART treatment \>3 years with suppression of plasma viral level below the limit of quantitation (\
Source: ClinicalTrials.gov (NCT06819176). StuddyBuddy aggregates publicly available trial information.
