LAST UPDATED
October 02, 2024
Clinicaltrials.gov ID
OVERVIEW
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 (CALIBRATE)
PROTOCOL SUMMARY
The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
November 2019 - October 2021
Study Type
Interventional
Study Phase
Phase 2
Product
Oral Lenacapavir, F/TAF, Subcutaneous Lenacapavir, TAF, BIC, B/F/TAF
Eligibility information
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 ribonucleic acid (RNA) ≥ 200 copies/mL at screening
- Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening
Exclusion criteria
- Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (53)
Valleywise Community Health Center - McDowell
Phoenix, Arizona, United States, 85004
Ruane Clinical Research Group Inc
Los Angeles, California, United States, 90036
Mills Clinical Research at Men's Health Foundation
Los Angeles, California, United States, 90069
Eisenhower Health Center at Rimrock
Palm Springs, California, United States, 92264
University of Colorado, Denver, University of Colorado Hospital
Aurora, Colorado, United States, 80045
Yale University; School of Medicine
New Haven, Connecticut, United States, 06510
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Whitman-Walker Institute, Inc.
Washington D.C., District of Columbia, United States, 20009
Washington Health Institute
Washington D.C., District of Columbia, United States, 20017
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, United States, 33140
Orlando Immunology Center
Orlando, Florida, United States, 32803-1851
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States, 33614
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33401
August University Medical Center
Augusta, Georgia, United States, 30912
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Mercer University, Department of Internal Medicine
Macon, Georgia, United States, 31201
Chatham County Health Department
Savannah, Georgia, United States, 31401
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States, 46077
St. John Newland Medical Associates
Southfield, Michigan, United States, 48075
East Carolina University, The Brody School of Medicine
Greenville, North Carolina, United States, 27858
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
Case Clinical Research Site/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States, 75246
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States, 76104
The Crofoot Research Center, Inc.
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States, 22003
MultiCare Rockwood HIV Critical Care Clinic
Spokane, Washington, United States, 99204
Instituto Dominicano de Estudios Virológicos (IDEV)
Santo Domingo, Dominican Republic, 10103
Proyecto ACTU, School of Medicine, University of Puerto Rico
San Juan, Puerto Rico, 00935
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