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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
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date December 9, 2020
Actual Study Start Date  ICMJE November 21, 2019
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE HIV-1-infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Oral Lenacapavir
    • Drug: Subcutaneous Lenacapavir
    • Drug: Failing ARV Regimen
    • Drug: Optimized Background Regimen (OBR)
  • 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.

    Interventions:
    • Drug: Oral Lenacapavir
    • Drug: Placebo oral tablet
    • Drug: Subcutaneous Lenacapavir
    • Drug: Failing ARV Regimen
    • Drug: Optimized Background Regimen (OBR)
  • 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.

    Interventions:
    • Drug: Oral Lenacapavir
    • Drug: Subcutaneous Lenacapavir
    • Drug: Optimized Background Regimen (OBR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Canada,   Dominican Republic,   France,   Germany,   Italy,   Japan,   South Africa,   Spain,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04150068
Other Study ID Numbers  ICMJE GS-US-200-4625
2019-003814-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP