Clincosm LogoSign in Get a demo

CALIBRATE: Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV

Sponsor
Gilead Sciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04143594
Collaborator
(none)
183
Enrollment
53
Locations
4
Arms
41.3
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with HIV (PLWH).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV
Actual Study Start Date :
Nov 22, 2019
Actual Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lenacapavir, F/TAF, and TAF

Induction: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily emtricitabine/tenofovir alafenamide (F/TAF) 200/25mg from Day 1 onwards for a total of 28 weeks. On Day 15 participants will receive subcutaneous (SC) lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin taking oral daily TAF 25 mg. May require oral weekly bridging if an SC injection of GS-6207 cannot be administered for any reason within the protocol visit window. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily TAF 25 mg from Week 80 onwards.

Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Names:
  • GS-6207

    • Drug: F/TAF
    Tablets administered without regard to food
    Other Names:
  • Descovy®

    • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other Names:
  • GS-6207

    • Drug: TAF
    Tablets administered without regard to food
    Experimental: Lenacapavir, F/TAF, and BIC

    Induction: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily F/TAF 200/25 mg from Day 1 onward for a total of 28 weeks. On Day 15 participants will receive SC lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin oral daily bictegravir (BIC) 75 mg. May require oral weekly bridging if an SC injection of GS-6207 cannot be administered for any reason within the protocol visit window. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily bictegravir (BIC) 75 mg from Week 80 onwards.

    Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other Names:
  • GS-6207

    • Drug: F/TAF
    Tablets administered without regard to food
    Other Names:
  • Descovy®

    • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other Names:
  • GS-6207

    • Drug: BIC
    Tablets administered without regard to food
    Experimental: Lenacapavir and F/TAF

    Participants will receive oral lenacapavir 600 mg at Day 1 and Day 2. On Day 3, participants will begin oral daily lenacapavir 50 mg. Participants will begin oral daily F/TAF 200/25 mg from Day 1 onwards. Participants willing to continue the study beyond Week 80 will continue to receive oral daily lenacapavir 50 mg and oral daily F/TAF 200/25 mg from Week 80 onwards.

    Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other Names:
  • GS-6207

    • Drug: F/TAF
    Tablets administered without regard to food
    Other Names:
  • Descovy®

    		•
    Active Comparator: B/F/TAF

    Participants will receive oral daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg at Day 1 and throughout their participation in the study.

    Drug: B/F/TAF
    Tablets administered without regard to food
    Other Names:
  • Biktarvy®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 54 as Determined by the US FDA-defined Snapshot Algorithm [Week 54]

    Secondary Outcome Measures

    1. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm [Week 28]

    2. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm [Week 38]

    3. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm [Week 80]

    4. Change from Baseline in Log10 HIV-1 RNA at Week 28 [Baseline; Week 28]

    5. Change from Baseline in Log10 HIV-1 RNA at Week 38 [Baseline; Week 38]

    6. Change from Baseline in Log10 HIV-1 RNA at Week 54 [Baseline; Week 54]

    7. Change from Baseline in Log10 HIV-1 RNA at Week 80 [Baseline; Week 80]

    8. Change from Baseline in CD4+ Cell Count at Week 28 [Baseline; Week 28]

    9. Change from Baseline in CD4+ Cell Count at Week 38 [Baseline; Week 38]

    10. Change from Baseline in CD4+ Cell Count at Week 54 [Baseline; Week 54]

    11. Change from Baseline in CD4+ Cell Count at Week 80 [Baseline; Week 80]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to screening is permitted

    • HIV-1 RNA ≥ 200 copies/mL at screening

    • CD4+ cell count ≥ 200 cells/microliter at screening

    Key Exclusion Criteria:
    • Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Valleywise Community Health Center - McDowell Phoenix Arizona United States 85004
    2 Pueblo Family Physicians Phoenix Arizona United States 85015
    3 Ruane Clinical Research Group Inc Los Angeles California United States 90036
    4 Mills Clinical Research at Men's Health Foundation Los Angeles California United States 90069
    5 Eisenhower Health Center at Rimrock Palm Springs California United States 92264
    6 University of Colorado, Denver, University of Colorado Hospital Aurora Colorado United States 80045
    7 Denver Public Health Denver Colorado United States 80204
    8 Yale University; School of Medicine New Haven Connecticut United States 06510
    9 Georgetown University Hospital Washington District of Columbia United States 20007
    10 Whitman-Walker Institute, Inc. Washington District of Columbia United States 20009
    11 Washington Health Institute Washington District of Columbia United States 20017
    12 Midland Florida Clinical Research Center, LLC DeLand Florida United States 32720
    13 Midway Immunology and Research Center Fort Pierce Florida United States 34982
    14 Floridian Clinical Research Hialeah Florida United States 33016
    15 AIDS Healthcare Foundation - South Beach Miami Beach Florida United States 33140
    16 AHF-The Kinder Medical Group Miami Florida United States 33133
    17 Orlando Immunology Center Orlando Florida United States 32803-1851
    18 St. Joseph's Hospital Comprehensive Research Institute Tampa Florida United States 33614
    19 Triple O Research Institute, P.A. West Palm Beach Florida United States 33401
    20 Atlanta ID Group, PC Atlanta Georgia United States 30309
    21 August University Medical Center Augusta Georgia United States 30912
    22 Infectious Disease Specialists of Atlanta Decatur Georgia United States 30033
    23 Mercer University, Department of Internal Medicine Macon Georgia United States 31201
    24 Chatham County Health Department Savannah Georgia United States 31401
    25 Howard Brown Health Center Chicago Illinois United States 60613
    26 Northstar Healthcare Chicago Illinois United States 60657
    27 Indiana University Infectious Diseases Research Indianapolis Indiana United States 46077
    28 Be Well Medical Center Berkley Michigan United States 48072
    29 St. John Newland Medical Associates Southfield Michigan United States 48075
    30 KC CARE Health Center Kansas City Missouri United States 64111
    31 Montefiore Medical Center Bronx New York United States 10467
    32 AHF-Midtown New York New York United States 10001
    33 East Carolina University, The Brody School of Medicine Greenville North Carolina United States 27858
    34 Rosedale Infectious Diseases Huntersville North Carolina United States 28078
    35 University of Cincinnati Cincinnati Ohio United States 45267
    36 Case Clinical Research Site/University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    37 The Ohio State University Medical Center Columbus Ohio United States 43210
    38 Allegheny Health Network Pittsburgh Pennsylvania United States 15212
    39 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    40 Central Texas Clinical Research Austin Texas United States 78705
    41 St Hope Foundation Bellaire Texas United States 77401
    42 Prism Health North Texas Dallas Texas United States 75208
    43 North Texas Infectious Diseases Consultants, P.A. Dallas Texas United States 75246
    44 Texas Centers for Infectious Disease Associates Fort Worth Texas United States 76104
    45 The Crofoot Research Center, Inc. Houston Texas United States 77098
    46 DCOL Center for Clinical Research Longview Texas United States 75605
    47 Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) Annandale Virginia United States 22003
    48 Peter Shalit, M.D. Seattle Washington United States 98104
    49 MultiCare Rockwood HIV Critical Care Clinic Spokane Washington United States 99204
    50 Instituto Dominicano de Estudios Virológicos (IDEV) Santo Domingo Dominican Republic 10103
    51 Clinical Research Puerto Rico San Juan Puerto Rico 00909-1711
    52 HOPE Clinical Research San Juan Puerto Rico 00909
    53 Proyecto ACTU, School of Medicine, University of Puerto Rico San Juan Puerto Rico 00935

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT04143594
    Other Study ID Numbers:
    • GS-US-200-4334
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Emtricitabine tenofovir alafenamide

    Study Results

    No Results Posted as of Apr 27, 2022