Lenacapavir for HIV

Recruiting in Palo Alto (17 mi)

Overseen byChuen-Yen C Lau, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Pending...

Research Team

Chuen-Yen C Lau, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

This trial is for adults aged 18-75 with HIV who are in good health, have been on antiretroviral therapy (ART) for over 3 years with a suppressed viral load, and have a CD4+ T cell count above 200. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent illness, drug abuse, certain medication use, other infections like hepatitis B/C, and inability to undergo leukapheresis.

Inclusion Criteria

Able to provide informed consent

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

Confirmed HIV-1 infection

See 7 more

Exclusion Criteria

Laboratory abnormalities in specified parameters

I have not had an AIDS-defining illness in the last 3 years.

Pregnancy or lactation

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Treatment Details

Interventions

Lenacapavir (Virus Therapy)

Trial OverviewThe trial is testing Lenacapavir's ability to disrupt HIV reservoirs in people whose virus is already under control with ART. Participants will receive Lenacapavir intensification alongside their current treatment regimen to assess its impact on the size of the HIV reservoir.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionalExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

Participants who are not randomized to lenacapavir will remain on their current ART regimens.