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

Gilead Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: HIV-1 Infection

Treatments: Drug: B/F/TAF; Drug: ISL; Drug: LEN

Study type: Interventional

Funder types: Industry

Identifiers

NCT05052996

GS-US-563-6041

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

ISL+LEN

Experimental group

Description:

Participants will receive the following for at least 48 weeks: Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) Day 2: LEN only oral 600 mg (2 x 300 mg) Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg (2 x 1 mg)

Treatment:

Drug: LEN

Drug: ISL

B/F/TAF

Experimental group

Description:

Participants will receive the following for at least 48 weeks: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily After 48 weeks, participants will switch from B/F/TAF to ISL+LEN Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) Day 2: LEN only oral 600 mg (2 x 300 mg) Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.

Treatment:

Drug: LEN

Drug: ISL

Drug: B/F/TAF