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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

NCT06630299

Active Not RecruitingPhase 3

Sponsor: Gilead Sciences

Conditions: HIV-1-Infection

Interventions: ISL/LEN, Antiretroviral Combinations

Countries: United States, Argentina, Australia, Germany, Japan, Netherlands, Poland, Puerto Rico

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:

1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 weeks period prior to screening.
2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip") as long as it is not confirmed on 2 consecutive visits.
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
* Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Key Exclusion Criteria:

* Prior virologic failure.
* Prior use of, or exposure to, ISL or LEN.
* Active, serious infections requiring parenteral therapy within 30 days before randomization.
* Active tuberculosis infection.
* Acute hepatitis within 30 days before randomization.
* Hepatitis B virus (HBV) infection, as determined below at the screening visit:

1. positive HBV surface antigen OR
2. positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
* Any of the following laboratory values at screening:

1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
2. Alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN)
3. Direct bilirubin \> 1.5 x ULN
4. Platelets \< 50,000/μL
5. Hemoglobin \< 8.0 g/dL

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (100)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palm Springs, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami Gardens, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Berkley, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Hillsborough, New Jersey, United States
Newark, New Jersey, United States
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