Study Details

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)

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

November 2019 - September 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

Pueblo Family Physicians

Phoenix, Arizona, United States, 85015

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

Denver Public Health

Denver, Colorado, United States, 80204

Yale University; School of Medicine

New Haven, Connecticut, United States, 06510

Georgetown University Hospital

Washington, District of Columbia, United States, 20007

Whitman-Walker Institute, Inc.

Washington, District of Columbia, United States, 20009

Washington Health Institute

Washington, District of Columbia, United States, 20017

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

Floridian Clinical Research

Hialeah, Florida, United States, 33016

AIDS Healthcare Foundation - South Beach

Miami Beach, Florida, United States, 33140

AHF-The Kinder Medical Group

Miami, Florida, United States, 33133

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

Atlanta ID Group, PC

Atlanta, Georgia, United States, 30309

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

Howard Brown Health Center

Chicago, Illinois, United States, 60613

Northstar Healthcare

Chicago, Illinois, United States, 60657

Indiana University Infectious Diseases Research

Indianapolis, Indiana, United States, 46077

Be Well Medical Center

Berkley, Michigan, United States, 48072

St. John Newland Medical Associates

Southfield, Michigan, United States, 48075

KC CARE Health Center

Kansas City, Missouri, United States, 64111

Montefiore Medical Center

Bronx, New York, United States, 10467

AHF-Midtown

New York, New York, United States, 10001

East Carolina University, The Brody School of Medicine

Greenville, North Carolina, United States, 27858

Rosedale Infectious Diseases

Huntersville, North Carolina, United States, 28078

University of Cincinnati

Cincinnati, Ohio, United States, 45267

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

Central Texas Clinical Research

Austin, Texas, United States, 78705

St Hope Foundation

Bellaire, Texas, United States, 77401

Prism Health North Texas

Dallas, Texas, United States, 75208

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

Peter Shalit, M.D.

Seattle, Washington, United States, 98104

MultiCare Rockwood HIV Critical Care Clinic

Spokane, Washington, United States, 99204

Instituto Dominicano de Estudios Virológicos (IDEV)

Santo Domingo, Dominican Republic, 10103

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909-1711

HOPE Clinical Research

San Juan, Puerto Rico, 00909

Proyecto ACTU, School of Medicine, University of Puerto Rico

San Juan, Puerto Rico, 00935

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