HIV-1-infection Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed
| Verified date | December 2021 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
| Status | Completed |
| Enrollment | 567 |
| Est. completion date | February 10, 2021 |
| Est. primary completion date | December 4, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: - Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods: - = 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit) - = 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit) - Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of = 6 or = 3 months, as applicable) preceding the screening visit - Plasma HIV-1 RNA levels < 50 copies/mL at screening visit - Estimated Glomerular Filtration Rate (eGFR) = 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance - No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure - Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medizinische Universitat Wien, Universitatsklinik fur Dermatologie | Wien | |
| Canada | Kaye Edmonton Clinic | Edmonton | Alberta |
| Canada | Chronical Viral Illness Service/McGill University Health Care (MUHC) | Montréal | Quebec |
| Canada | Clinique de Médecine Urbaine du Quartier Latin | Montréal | Quebec |
| Canada | Maple Leaf Research / Maple Leaf Medical Clinic | Toronto | Ontario |
| Canada | Spectrum Health Clinic | Vancouver | British Columbia |
| Canada | Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg | Winnipeg | Manitoba |
| France | Hôpital Saint-André | Bordeaux | |
| France | Hôpital Croix-Rousse | Lyon | |
| France | Hôpital Gui de Chauliac, CHU de Montpellier | Montpellier | |
| France | CHU de Nice-l'Archet | Nice | |
| France | AP-HP Hôpital Tenon | Paris | |
| France | CHU Bichat | Paris | |
| France | Hôpital Saint-Antoine | Paris | |
| France | Hôpital Saint-Louis | Paris | |
| Germany | EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH | Berlin | |
| Germany | zibp Zentrum für Infektiologie Berlin Prenzlauer Berg | Berlin | |
| Germany | Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie | Bonn | |
| Germany | Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I | Cologne | |
| Germany | Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz | Essen | |
| Germany | Infektiologikum Frankfurt | Frankfurt am Main | |
| Germany | Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68 | Frankfurt am Main | |
| Germany | ICH Study Center GmbH & Co. KG | Hamburg | |
| Germany | Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie | Hamburg | |
| Puerto Rico | Instituto de Investigacion Cientifica del Sur | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico | San Juan | |
| Puerto Rico | Hope Clinical Research | San Juan | |
| Puerto Rico | Proyecto ACTU | San Juan | |
| United States | Southwest CARE Center | Albuquerque | New Mexico |
| United States | AIDS Research Consortium of Atlanta | Atlanta | Georgia |
| United States | Emory Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia |
| United States | AU Medical Center | Augusta | Georgia |
| United States | University of Colorado Denver, University of Colorado Hospital | Aurora | Colorado |
| United States | Central Texas Clinical Research | Austin | Texas |
| United States | Be Well Medical Center | Berkley | Michigan |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Community Research Initiative of New England | Boston | Massachusetts |
| United States | Jacobi Medical Center | Bronx | New York |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina (MUSC) | Charleston | South Carolina |
| United States | Palmetto Health Richland (Regulatory and Study Supply Shipping) | Columbia | South Carolina |
| United States | AIDS Arms Inc/ Trinity Health and Wellness Center | Dallas | Texas |
| United States | North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas |
| United States | Infectious Disease Specialists of Atlanta | Decatur | Georgia |
| United States | Midland Florida Clinical Research Center, LLC | DeLand | Florida |
| United States | Duke University Heath System | Durham | North Carolina |
| United States | Gary J. Richmond, M.D., P.A. | Fort Lauderdale | Florida |
| United States | Therafirst Medical Center | Fort Lauderdale | Florida |
| United States | Midway Immunology and Research Center | Fort Pierce | Florida |
| United States | Metro West Medical Center | Framingham | Massachusetts |
| United States | East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care | Greenville | North Carolina |
| United States | John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako | Honolulu | Hawaii |
| United States | Research Access Network | Houston | Texas |
| United States | The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA) | Houston | Texas |
| United States | Therapeutic Concepts, PA | Houston | Texas |
| United States | Rosedale Infectious Diseases | Huntersville | North Carolina |
| United States | Kansas City CARE Clinic | Kansas City | Missouri |
| United States | DCOL Center for Clinical Research | Longview | Texas |
| United States | Mills Clinical Research | Los Angeles | California |
| United States | Ruane Clinical Research Group Inc. | Los Angeles | California |
| United States | University of Louisville 550 Clinic | Louisville | Kentucky |
| United States | Mercer University, Department of Internal Medicine | Macon | Georgia |
| United States | North Shore University Hospital/Division of Infectious Diseases | Manhasset | New York |
| United States | University of Miami Divison of Infectious Diseases Clinical Research Unit | Miami | Florida |
| United States | AIDS Healthcare Foundation - South Beach | Miami Beach | Florida |
| United States | Abbott Northwestern Hospital part of Allina Health | Minneapolis | Minnesota |
| United States | Hennepin County Medical Center, Positive Care Clinic | Minneapolis | Minnesota |
| United States | Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center | Newark | New Jersey |
| United States | Highland Hospital - Alameda Health System | Oakland | California |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | AHF-Pensacola | Pensacola | Florida |
| United States | Spectrum Medical Group | Phoenix | Arizona |
| United States | Cares Community Health | Sacramento | California |
| United States | Kaiser Permanente | Sacramento | California |
| United States | Southampton Healthcare, Inc. | Saint Louis | Missouri |
| United States | Hepatitis/HIV Clinical Trials Group (HHCTG) | San Francisco | California |
| United States | Kaiser Permanente | San Francisco | California |
| United States | Kaiser Permanente, Department of Infectious Diseases | San Leandro | California |
| United States | Southwest CARE Center | Santa Fe | New Mexico |
| United States | Chatham County Health Department | Savannah | Georgia |
| United States | Peter Shalit, M.D. | Seattle | Washington |
| United States | MultiCare Rockwood HIV Critical Care Clinic | Spokane | Washington |
| United States | Claudia T Martorell, MD., LLC d/b/a The Research Institute | Springfield | Massachusetts |
| United States | Infectious Disease Research Institute Inc | Tampa | Florida |
| United States | St. Joseph's Hospital Comprehensive Research Institute | Tampa | Florida |
| United States | AIDS Research and Treatment Center of the Treasure Coast | Vero Beach | Florida |
| United States | Dupont Circle Physician's Group | Washington | District of Columbia |
| United States | Providence Hospital Center for Infectious Diseases | Washington | District of Columbia |
| United States | The GW Medical Faculty Associates | Washington | District of Columbia |
| United States | Whitman-Walker Institute | Washington | District of Columbia |
| United States | Triple O Research Institute, P.A. | West Palm Beach | Florida |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Austria, Canada, France, Germany, Puerto Rico,
Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Prese — View Citation
Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppre — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With HIV-1 RNA = 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA = 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | |
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 |
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