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Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

NCT05052996

Active Not RecruitingPhase 2

Sponsor: Gilead Sciences

Conditions: HIV-1 Infection

Interventions: ISL, LEN, B/F/TAF, ISL/LEN FDC

Countries: United States

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening.
* Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening.
* Plasma HIV-1 RNA \< 50 copies/mL at screening.

Key Exclusion Criteria:

* History of prior virologic failure while receiving treatment for HIV-1.
* Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN).
* Active, serious infections requiring parenteral therapy \< 30 days before randomization.
* Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
* Any of the following laboratory values at screening:

  * Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
* CD4+ T-cells \< 200 cells/mm\^3 (Cohort 1); CD4+ T-cells \< 350 cells/mm\^3 (cohort 2).
* Absolute lymphocyte count \< 900 cells/mm\^3 (cohort 2).
* Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.
* Individuals who plan to continue breastfeeding during the study.
* Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2).

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

Locations (44)

Beverly Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Palm Springs, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Lake Worth, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Berkley, Michigan, United States
New Brighton, Minnesota, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
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