Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06819176

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-20

50

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • Willing to comply with study procedures and available for the study duration
  • Aged 18 to 75 years
  • In generally good health with a primary healthcare provider for HIV management and willing to maintain care
  • Confirmed HIV-1 infection
  • HIV DNA reservoir size greater than 300 copies per 1 million CD4+ T cells
  • CD4+ T cell count above 200 cells/mm³ at screening
  • Continuous ART treatment for more than 3 years with plasma viral load below 40 copies/mL, allowing up to 2 viral blips ≤200 copies/mL in the prior 48 weeks if viral load returned below 40 copies/mL afterwards
  • Negative pregnancy test within 48 hours before day 0 for participants who can become pregnant
  • Agreement to use one acceptable method of contraception from 10 days before first lenacapavir dose through follow-up for participants who can become pregnant
Not Eligible

You will not qualify if you...

  • History of AIDS-defining illness within 3 years before enrollment
  • Use of systemic corticosteroids, immunosuppressive cancer treatments, interleukins, interferons, systemic chemotherapy, or other significant medications within 6 months
  • Clinically significant acute or chronic medical conditions other than HIV that could interfere with participation
  • Hepatitis B or C infection indicated by positive hepatitis B surface antigen or HCV RNA (positive HCV antibody with negative RNA is allowed)
  • Pregnancy or lactation
  • Receipt of licensed vaccines within 2 weeks prior to enrollment
  • Use of other investigational agents within 28 days before enrollment or during the study
  • Use of systemic immunosuppressive medications within 3 months prior to enrollment except specified topical or short-term corticosteroids
  • Active drug or alcohol abuse or behavior interfering with study adherence
  • Laboratory abnormalities including low neutrophil count, low hemoglobin, low platelets, elevated liver enzymes or bilirubin, or reduced kidney function
  • Inability to undergo leukapheresis due to poor venous access or medical reasons
  • Concurrent treatment with specified medications including certain antiarrhythmics, anticoagulants, anticonvulsants, antiretrovirals, antimycobacterials, corticosteroids, ergot derivatives, herbal products, statins, narcotic analgesics, opioid treatments, PDE-5 inhibitors, and sedatives
  • Other medical findings that may pose additional risk, interfere with participation, or affect data quality as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

Loading map...

Research Team

K

Kathleen R Gittens

CONTACT

C

Chuen-Yen C Lau, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here