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NCT Number: NCT04150068

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

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 for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1-infection

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Vancouver ID Research and Care Centre Society, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Treatment and study plan

Oral Lenacapavir

Drug

Tablets administered without regard to food

Other names: Sunlenca®, GS-6207

Oral Lenacapavir Placebo

Drug

Tablets administered without regard to food

Subcutaneous Lenacapavir

Drug

Administered in the abdomen via subcutaneous injections

Other names: Sunlenca®, GS-6207

Failing ARV Regimen

Drug

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.

Optimized Background Regimen (OBR)

Drug

Optimized background regimen as prescribed by the Investigator

Primary outcomes

  1. Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period

    Time frame: Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15

Secondary outcomes

  1. Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  2. Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  3. Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 52 (52 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in cohort 1 with plasma HIV-1 RNA < 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Percentages were rounded off.

  4. Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 52 (52 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in cohort 1 with plasma HIV-1 RNA < 200 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Percentages were rounded off.

  5. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 104 (104 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 50 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Percentages were rounded off.

  6. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 104 (104 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 200 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Percentages were rounded off.

  7. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 156 (156 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 50 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Percentages were rounded off.

  8. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm

    Time frame: Week 156 (156 weeks after first dose of subcutaneous lenacapavir)

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA < 200 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Percentages were rounded off.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

Acronym: CAPELLA

Important dates

Study start
2019
Primary completion
2020
Study completion
2027
First posted
Nov 4, 2019
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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