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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Able to provide informed consent.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Aged 18 years to 75 years.
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.
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, lenacapavir, 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.
Parallel
Lenacapavir
DrugLenacapavir (Sunlenca) is a prescription drug approved by the Food and Drug Administration (FDA) for the treatment of people living with multidrug-resistant HIV. Lenacapavir is always used as part of a combination ART regimen. Participants will receive lenacapavir at 927 mg by subcutaneous injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48.
Changes in the intact HIV proviral reservoir size, measured by IPDA in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96.
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.
Changes in the residual HIV plasma viremia (1-39 copies/mL) from baseline to weeks 12, 24, 48, 72, and 96 in the lenacapavir and control arm.
To compare the effect of the presence or absence of lenacapavir on residual plasma viremia (\<40 copies/mL) in PWH who have been receiving virologically suppressive (\<40 copies/mL) ART for greater than 3 years.
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