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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| ClinicalTrials.gov Identifier: NCT04150068 |
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Recruitment Status :
Active, not recruiting
First Posted : November 4, 2019
Results First Posted : October 20, 2021
Last Update Posted : February 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV-1-infection | Drug: Oral Lenacapavir Drug: Oral Lenacapavir Placebo Drug: Subcutaneous Lenacapavir Drug: Failing ARV Regimen Drug: Optimized Background Regimen (OBR) | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | November 21, 2019 |
| Actual Primary Completion Date : | October 5, 2020 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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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:
Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections
Other Names:
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 |
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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:
Drug: Oral Lenacapavir Placebo Tablets administered without regard to food Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections
Other Names:
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 |
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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:
Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections
Other Names:
Drug: Optimized Background Regimen (OBR) Optimized background regimen as prescribed by the Investigator |
- 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 ]
- 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.
- 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.
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150068
Show 75 study locations
| Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT04150068 |
| Other Study ID Numbers: |
GS-US-200-4625 2019-003814-16 ( EudraCT Number ) |
| First Posted: | November 4, 2019 Key Record Dates |
| Results First Posted: | October 20, 2021 |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infections Communicable Diseases HIV Infections Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Genital Diseases Urogenital Diseases Immunologic Deficiency Syndromes Immune System Diseases |