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Purpose

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR).

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic) - Currently receiving a stable failing ARV regimen for > 8 weeks - Have HIV-1 RNA ≥ 400 copies/mL at screening - Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV) - Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen - Able and willing to receive an OBR together with lenacapavir - No Hepatitis C virus (HCV) ongoing infection Note: Other protocol defined Inclusion/

Exclusion Criteria

may apply.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1A: Lenacapavir 		Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at Cohort Selection visit compared with screening visit will receive oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) lenacapavir 927 mg and will initiate an OBR at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants will receive their subsequent SC lenacapavir injection at Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other names:
    • Sunlenca®
    • GS-6207
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other names:
    • Sunlenca®
    • GS-6207
  • Drug: Failing ARV Regimen
    Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
  • Drug: Optimized Background Regimen (OBR)
    Optimized background regimen as prescribed by the Investigator
Placebo Comparator
Cohort 1B: Placebo to Lenacapavir 		Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit will receive oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral lenacapavir 600 mg on Days 15 and 16 and 300 mg on Day 22, and will initiate an OBR on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg while continuing OBR. Participants will receive their next SC injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue study in the country.
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other names:
    • Sunlenca®
    • GS-6207
  • Drug: Oral Lenacapavir Placebo
    Tablets administered without regard to food
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other names:
    • Sunlenca®
    • GS-6207
  • Drug: Failing ARV Regimen
    Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
  • Drug: Optimized Background Regimen (OBR)
    Optimized background regimen as prescribed by the Investigator
Experimental
Cohort 2: Lenacapavir 		Participants with a ≥ 0.5 log10 copies/mL HIV-1 RNA decline at the Cohort Selection Visit compared with the screening visit or with HIV-1 RNA < 400 copies/mL or if Cohort 1 is fully enrolled will receive oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants will receive SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants will receive their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other names:
    • Sunlenca®
    • GS-6207
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other names:
    • Sunlenca®
    • GS-6207
  • Drug: Optimized Background Regimen (OBR)
    Optimized background regimen as prescribed by the Investigator

More Details

Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.