The trial is taking place at:
C

Chatham County Health Department | Clinical Trials Unit

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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 (CAPELLA)

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Gilead Sciences

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

HIV-1-infection

Treatments

Drug: Optimized Background Regimen (OBR)
Drug: Failing ARV Regimen
Drug: Subcutaneous Lenacapavir
Drug: Oral Lenacapavir Placebo
Drug: Oral Lenacapavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT04150068
2019-003814-16 (EudraCT Number)
GS-US-200-4625

Details and patient eligibility

About

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).

Enrollment

72 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

72 participants in 3 patient groups, including a placebo group

Cohort 1A: Lenacapavir
Experimental group
Description:
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.
Treatment:
Drug: Oral Lenacapavir
Drug: Subcutaneous Lenacapavir
Drug: Failing ARV Regimen
Drug: Optimized Background Regimen (OBR)
Cohort 1B: Placebo to Lenacapavir
Placebo Comparator group
Description:
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.
Treatment:
Drug: Oral Lenacapavir
Drug: Oral Lenacapavir Placebo
Drug: Subcutaneous Lenacapavir
Drug: Failing ARV Regimen
Drug: Optimized Background Regimen (OBR)
Cohort 2: Lenacapavir
Experimental group
Description:
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.
Treatment:
Drug: Oral Lenacapavir
Drug: Subcutaneous Lenacapavir
Drug: Optimized Background Regimen (OBR)

Trial documents
3

Trial contacts and locations

75

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Data sourced from clinicaltrials.gov

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