Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2020 by Gilead Sciences

Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT04143594

First received: October 28, 2019
Last updated: May 29, 2020
Last Verified: May 2020
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV-1-infection

Drug : Oral Lenacapavir
Drug : F/TAF
Drug : Subcutaneous Lenacapavir
Drug : TAF
Drug : BIC
Drug : B/F/TAF
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 54 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 54 ]
Secondary Outcome Measures:
  • Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 28 ]
  • Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 38 ]
  • Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 80 ]
  • Change from Baseline in Log10 HIV-1 RNA at Week 28 [ Time Frame: Baseline; Week 28 ]
  • Change from Baseline in Log10 HIV-1 RNA at Week 38 [ Time Frame: Baseline; Week 38 ]
  • Change from Baseline in Log10 HIV-1 RNA at Week 54 [ Time Frame: Baseline; Week 54 ]
  • Change from Baseline in Log10 HIV-1 RNA at Week 80 [ Time Frame: Baseline; Week 80 ]
  • Change from Baseline in CD4+ Cell Count at Week 28 [ Time Frame: Baseline; Week 28 ]
  • Change from Baseline in CD4+ Cell Count at Week 38 [ Time Frame: Baseline; Week 38 ]
  • Change from Baseline in CD4+ Cell Count at Week 54 [ Time Frame: Baseline; Week 54 ]
  • Change from Baseline in CD4+ Cell Count at Week 80 [ Time Frame: Baseline; Week 80 ]

Estimated Enrollment: 175
Study Start Date: November 22, 2019
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 900 mg. Maintenance: Participants will receive SC lenacapavir 900 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. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 900 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 Name: GS-6207
Drug: F/TAF

Tablets administered without regard to food

Other Name: Descovy®
Drug: Subcutaneous Lenacapavir

Administered in the abdomen via subcutaneous injections

Other Name: 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 900 mg. Maintenance: Participants will receive SC lenacapavir 900 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. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 900 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 Name: GS-6207
Drug: F/TAF

Tablets administered without regard to food

Other Name: Descovy®
Drug: Subcutaneous Lenacapavir

Administered in the abdomen via subcutaneous injections

Other Name: 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 Name: GS-6207
Drug: F/TAF

Tablets administered without regard to food

Other Name: 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 Name: Biktarvy®
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04143594

Contacts

Contact:   Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations

United States, Alabama
Alabama Medical Group, PC (Drug Shipment Address) Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Valleywise Community Health Center - McDowell Recruiting
Phoenix, Arizona, United States, 85004
Pueblo Family Physicians Recruiting
Phoenix, Arizona, United States, 85015
United States, California
Ruane Clinical Research Group Inc Recruiting
Los Angeles, California, United States, 90036
Mills Clinical Research at Men's Health Foundation Recruiting
Los Angeles, California, United States, 90069
Eisenhower Health Center at Rimrock Recruiting
Palm Springs, California, United States, 92264
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
United States, Colorado
University of Colorado, Denver, University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Whitman-Walker Institute, Inc. Recruiting
Washington, District of Columbia, United States, 20009
Washington Health Institute Recruiting
Washington, District of Columbia, United States, 20017
United States, Florida
Midland Florida Clinical Research Center, LLC Recruiting
DeLand, Florida, United States, 32720
Midway Immunology and Research Center Recruiting
Fort Pierce, Florida, United States, 34982
Floridian Clinical Research Recruiting
Hialeah, Florida, United States, 33016
AIDS Healthcare Foundation - South Beach Recruiting
Miami Beach, Florida, United States, 33140
AHF-The Kinder Medical Group Recruiting
Miami, Florida, United States, 33133
University of Miami Department of Medicine Division of Infectious Disease Recruiting
Miami, Florida, United States, 33136
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803-1851
AHF-Pensacola Recruiting
Pensacola, Florida, United States, 32504
St. Joseph's Hospital Comprehensive Research Institute Recruiting
Tampa, Florida, United States, 33614
Triple O Research Institute, P.A. Recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory Hospital Midtown Infectious Disease Clinic Recruiting
Atlanta, Georgia, United States, 30308
Atlanta ID Group, PC Recruiting
Atlanta, Georgia, United States, 30309
Infectious Disease Specialists of Atlanta Recruiting
Decatur, Georgia, United States, 30033
Mercer University, Department of Internal Medicine Recruiting
Macon, Georgia, United States, 31201
Chatham County Health Department Recruiting
Savannah, Georgia, United States, 31401
United States, Illinois
Howard Brown Health Center Recruiting
Chicago, Illinois, United States, 60613
Northstar Healthcare Recruiting
Chicago, Illinois, United States, 60657
United States, Indiana
Indiana University Infectious Diseases Research Recruiting
Indianapolis, Indiana, United States, 46077
United States, Louisiana
University Medical Center - New Orleans (UMCNO) Recruiting
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Claudia T. Martorell, MD d/b/a The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
United States, Michigan
Be Well Medical Center Recruiting
Berkley, Michigan, United States, 48072
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
St. John Newland Medical Associates Recruiting
Southfield, Michigan, United States, 48075
United States, Missouri
KC CARE Health Center Recruiting
Kansas City, Missouri, United States, 64111
Southampton Healthcare, Inc. Recruiting
Saint Louis, Missouri, United States, 63139
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
North Shore University Hospital/Division of Infectious Diseases Recruiting
Manhasset, New York, United States, 11030
AHF-Midtown Recruiting
New York, New York, United States, 10001
United States, North Carolina
Atrium Health - Myer's Park Infectious Disease Clinic Recruiting
Charlotte, North Carolina, United States, 28207
East Carolina University, The Brody School of Medicine Recruiting
Greenville, North Carolina, United States, 27858
Rosedale Infectious Diseases Recruiting
Huntersville, North Carolina, United States, 28078
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Central Texas Clinical Research Recruiting
Austin, Texas, United States, 78705
St Hope Foundation Recruiting
Bellaire, Texas, United States, 77401
Prism Health North Texas Recruiting
Dallas, Texas, United States, 75208
North Texas Infectious Diseases Consultants, P.A. Recruiting
Dallas, Texas, United States, 75246
Texas Centers for Infectious Disease Associates Recruiting
Fort Worth, Texas, United States, 76104
The Crofoot Research Center, Inc. Recruiting
Houston, Texas, United States, 77098
DCOL Center for Clinical Research Recruiting
Longview, Texas, United States, 75605
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) Recruiting
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, M.D. Recruiting
Seattle, Washington, United States, 98104
MultiCare Rockwood HIV Critical Care Clinic Recruiting
Spokane, Washington, United States, 99204
Puerto Rico
Clinical Research Puerto Rico Recruiting
San Juan, Puerto Rico, 00909-1711
HOPE Clinical Research Recruiting
San Juan, Puerto Rico, 00909
Proyecto ACTU, School of Medicine, University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00935

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT04143594   History of Changes  
Other Study ID Numbers: GS-US-200-4334  
Study First Received: October 28, 2019  
Last Updated: May 29, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.