Lenacapavir to Reduce HIV Reservoirs

This study is looking at whether adding Lenacapavir (Sunlenca) to standard HIV medication can help reduce the amount of HIV hidden in the body. Even with effective treatment, HIV can remain in certain cells, called reservoirs. Researchers want to see if Lenacapavir can shrink these reservoirs in people aged 18 to 75 who have been successfully treated for HIV for at least three years. The main goal is to measure changes in the size of these HIV reservoirs in your blood over 96 weeks. This study is currently unclear about its recruitment status and plans to enroll 50 participants.

Study design
This study will randomly assign participants to either continue their current HIV medication plus Lenacapavir, or continue their current medication alone. Up to 50 people will participate.
What's involved
You would have 13 clinic visits over 2 years. This includes blood draws and a procedure called leukapheresis (where blood is drawn, certain cells are removed, and the rest is returned to you) at specific time points.
Compensation
Not stated in the trial record.
Follow-up
Participants in the Lenacapavir group will be followed for 48 weeks after their last injection. All participants will have their HIV reservoirs monitored through week 96.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06819176

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

Recruiting
PHASE1Ages 18–75InterventionalBasic science
National Institute of Allergy and Infectious Diseases (NIAID)
~50 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Lenacapavir

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Through week 96.
Human Immunodeficiency Virus
1 sites across 1 states
Maryland1
  • Chuen-Yen C Lau, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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  • 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.Through week 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.