A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintained on a Ritonavir Boosted Protease Inhibitor Containing Antiretroviral Regimen
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate
the safety and efficacy of switching from fixed dose ABC/3TC to fixed dose FTC/TDF in
virologically suppressed, HIV-1 infected subjects maintained on a PI/r-containing ARV
regimen.
Subjects were stratified based on the PI/r (ie, lopinavir/ritonavir [LPV/r] versus other
boosted PIs) in their regimen, and the presence versus absence of comorbidities at screening
(diabetes mellitus or cardiovascular disease such as hypertension, coronary artery disease,
hyperlipidemia, history of myocardial infarction, cardiomyopathy, valvular heart disease,
congenital heart disease, stroke, peripheral vascular disease, or arrhythmias). Subjects
were randomized 1:1 to switch to FTC/TDF+PI/r or to continue on their existing regimen.
Subjects received study treatment for 48 weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.
Baseline to 48 weeks
No
Todd Fralich, MD
Study Director
Gilead Sciences
United States: Institutional Review Board
GS-US-164-0216
NCT00724711
July 2008
April 2011
Name | Location |
---|---|
Henry Ford Hospital | Detroit, Michigan 48202 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Rochester Medical Center | Rochester, New York 14642 |
Baylor University Medical Center | Dallas, Texas 75246 |
Hennepin County Medical Center | Minneapolis, Minnesota |
University of Florida | Gainesville, Florida 32610-0277 |
University of Louisville | Louisville, Kentucky 40202 |
University of Miami | Miami, Florida 33136 |
Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
Clinical Pharmacology Services | Tampa, Florida |
Kaiser Permanente | Denver, Colorado 80204-4507 |
Saint Michael's Medical Center | Newark, New Jersey 07102 |
UT Southwestern Medical Center at Dallas | Dallas, Texas 75390 |
Abbott Northwestern Hospital | Minneapolis, Minnesota 55430 |
Howard Brown Health Center | Chicago, Illinois 60613 |
Health For Life Clinic, PLLC | Little Rock, Arkansas 72207 |
Vista Medical Partners | Beverly Hills, California 90210 |
AHF | Beverly Hills, California 90211 |
Pacific Oaks Medical Group | Beverly Hills, California 90211 |
Center for Special Immunology | Fountain Valley, California 92708 |
Living Hope Clinical Foundation | Long Beach, California 90813 |
Jeffrey Goodman Special Care Clinic | Los Angeles, California 90028 |
Anthony M Mills, MD | Los Angeles, California 90069 |
Peter J. Ruane, MD, Inc. | Los Angeles, California 90036 |
Orange Coast Medical Group | Newport Beach, California 92663 |
Tarzana Treatment Center | Northridge, California 91324 |
Alameda County Medical Center | Oakland, California 94602 |
Health Management Institute, Inc. | San Francisco, California 94114 |
Metropolis Medical | San Francisco, California 94115 |
Blick Medical Associates | Norwalk, Connecticut 06851 |
Gary Richmond, MD, PA, Inc. | Fort Lauderdale, Florida 33316 |
Life Way Inc. | Fort Lauderdale, Florida 33308 |
Therafirst Medical Centers | Fort Lauderdale, Florida 33308 |
HIV Clinical Research | Ft. Lauderdale, Florida 33311 |
Biogenomx Research Institute, LLC | Ft. Lauderdale, Florida 33306 |
The Kinder Medical Group | Miami, Florida 33133 |
Community Health of South Florida Inc. | Miami, Florida 33190 |
South Florida Infectious Diseases and Tropical Medicine Center | Miami, Florida 33176 |
Wohlfeiler, Piperato and Associates, LLC | Miami Beach, Florida 33139 |
Orlando Immunology Center | Orlando, Florida 32803 |
Infectious Diseases Associates of NW FL | Pensacola, Florida 32504 |
Associates in Infectious Diseases | Port St. Lucie, Florida 34952 |
Barry M. Rodwick, M.D. | Safety Harbor, Florida 34695 |
Infectious Disease Research Institute, Inc. | Tampa, Florida 33614 |
USF Health | Tampa, Florida 33602 |
Infectious Disease Solutions | Atlanta, Georgia 30309 |
Atlanta Infectious Disease Group, PC | Atlanta, Georgia 30309 |
Family Healthcare of Atlanta PC | Atlanta, Georgia 30318 |
Chatham County Health Department | Savannah, Georgia 31401 |
NorthStar Medical Center | Chicago, Illinois 60657 |
Chase Brexton Health Services | Baltimore, Maryland 21201 |
MetroWest Medical Center | Framingham, Massachusetts 01702 |
The Research Institute | Springfield, Massachusetts 01107 |
Community Research Initiative of New England - WEST | Springfield, Massachusetts 01107 |
Be Well Medical Center | Berkley, Michigan 48072 |
Michigan State University, College of Osteopathic Medicine | East Lansing, Michigan 48824 |
St. John Hospital Internal Medicine Clinic - Mack Office Building | Grosse Point Woods, Michigan 48236 |
ID Associates, PA | Hillsborough, New Jersey 08844 |
South Jersey Infectious Disease | Somers Point, New Jersey 08244 |
Upstate Infectious Diseases Associates | Albany, New York 23309 |
Greiger Clinic | Mount Vernon, New York 10550 |
Ricky K. Hsu, MD, PC | New York, New York 10011 |
AIDS Community Health Center | Rochester, New York 14604 |
ID Consultants, P.A. | Charlotte, North Carolina 28209 |
East Carolina University The Brody School of Medicine | Greenville, North Carolina 27858 |
Summa Health System Care Center | Akron, Ohio 44394 |
Central Texas Clinical Research | Austin, Texas 78705 |
North Texas Inf. Disease Consultants | Dallas, Texas 75246 |
Tarrant County Infectious Disease Associates | Fort Worth, Texas 76104 |
Valley AIDS Counsel | Harlingen, Texas 78550 |
Gordon E. Crofoot, MD, PA | Houston, Texas 77098 |
Therapeutic Concepts, PA | Houston, Texas 77004 |
Daniel Coulston, MD | Spokane, Washington 99204 |