Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With an Optimized Background Regimen 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
Last Update Posted : February 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV-1-infection | Drug: Oral Lenacapavir Drug: Placebo oral tablet 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 |
| Intervention Model Description: | Participants will be enrolled into Cohort 2 if Cohort 1 is fully enrolled or if they do not meet the criteria for randomization in Cohort 1. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Knowledge of treatment assignments will be masked during the Functional Monotherapy Period in Cohort 1. |
| 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 : | October 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1A Lenacapavir, Failing ARV Regimen, and OBR
Functional Monotherapy Period: Participants will receive oral lenacapavir 600 mg, 600mg, and 300 mg tablets on Days 1, 2, and 8 respectively while continuing their failing regimen (previous Antiretroviral (ARV) regimen). Maintenance Period: At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive subcutaneous (SC) lenacapavir 927 mg and initiate an optimized background regimen (OBR) (as prescribed by the Investigator). Participants will continue to receive SC lenacapavir 927 mg once every 6 months (26 weeks). Participants willing to continue beyond the study beyond Week 52 visit will receive SC lenacapavir every 6 months (26 weeks) starting at Week 52 visit, while continuing their OBR. |
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Name: GS-6207 Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections
Other Name: GS-6207 Drug: Failing ARV Regimen Failing antiretroviral 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, Lenacapavir, Failing ARV Regimen, and OBR
Cohort 1B: Functional Monotherapy Period: Participants will receive placebo on Days 1, 2, and 8 while continuing their failing regimen. Maintenance Period: At Day 15, participants will receive oral lenacapavir 600 mg and initiate an OBR (as prescribed by the Investigator). Participants will receive oral lenacapavir 600 mg and 300 mg at Day 16 and Day 22, respectively. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg while continuing their optimized background regimen. Participants will continue to receive SC lenacapavir 927 mg once every 6 months (26 weeks). Participants willing to continue beyond the study beyond Week 52 visit will receive SC lenacapavir every 6 months (26 weeks) starting at Week 52 visit, while continuing their OBR. |
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Name: GS-6207 Drug: Placebo oral tablet Tablets administered without regard to food Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections
Other Name: GS-6207 Drug: Failing ARV Regimen Failing antiretroviral 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 and OBR
Oral Lead-in Period: At Day 1, participants will receive oral lenacapavir 600 mg and initiate an OBR (as prescribed by the Investigator). Participants will receive oral lenacapavir 600 mg and 300 mg at Day 2 and Day 8, respectively, while continuing their OBR. Maintenance Period: At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg once every 6 months (26 weeks). Participants willing to continue beyond the study beyond Week 52 visit will receive SC lenacapavir every 6 months (26 weeks) starting at Week 52 visit, while continuing their OBR. |
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Name: GS-6207 Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections
Other Name: GS-6207 Drug: Optimized Background Regimen (OBR) Optimized background regimen as prescribed by the Investigator |
- Proportion of Participants in Cohort 1 Achieving ≥ 0.5 log10 Copies/mL Reduction from Baseline in HIV-1 RNA at the End of Functional Monotherapy Period. [ Time Frame: Up to 15 days ]
- Proportion 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 ]
- Proportion 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 ]
- Proportion 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 ]
- Proportion 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 antiretroviral (ARV) regimen for > 8 weeks
- Have HIV-1 RNA ≥ 400 copies/mL at screening
- Have multidrug resistance
- 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 optimized background regimen 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 |
| 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 |
| Last Update Posted: | February 8, 2021 |
| Last Verified: | February 2021 |
| 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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Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |