Safety and Efficacy Study of Switching From Epzicom to Truvada
SWIFT
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
1 other identifier
interventional
312
3 countries
80
Brief Summary
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration of treatment is 48 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2008
Typical duration for phase_4
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
April 19, 2012
CompletedMay 28, 2012
May 1, 2012
2.7 years
July 25, 2008
March 28, 2012
May 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (13)
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
Baseline to 48 weeks
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
Baseline to 48 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
48 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
48 weeks
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Baseline to 48 weeks
- +8 more secondary outcomes
Study Arms (2)
FTC/TDF (Truvada [TVD]) + PI/r
EXPERIMENTALParticipants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada \[TVD\]) for 48 weeks. The prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r
ACTIVE COMPARATORParticipants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
Interventions
FTC 200 mg/TDF 300 mg tablet, once a day
ABC 600 mg/3TC 300 mg tablet, once a day
Eligibility Criteria
You may qualify if:
- Adult (greater than or equal to 18 years) males or non-pregnant, non-lactating females
- HIV-1 infected subjects currently receiving a ritonavir-boosted protease inhibitor and fixed-dose ABC/3TC regimen continuously for greater than or equal to 3 months
- HIV infection as documented by a validated HIV antibody enzyme-linked immunosorbent assay (ELISA) and confirmed by one of the following:
- Immunoblot detection of HIV antibody
- Positive HIV-1 blood culture
- Positive HIV-1 serum P24 antigen
- HIV-1 plasma viremia greater than 1000 copies/mL by polymerase chain reaction (PCR) or branched-chain deoxyribonucleic acid (bDNA) method
- Detection of proviral DNA by PCR
- (If confirmation of HIV infection is not available then repeat testing of HIV antibody will be required)
- Two consecutive plasma HIV-1 RNA concentration less than 200 copies/mL. The two HIV-1 RNA determinations ensure that the subject has been virologically-suppressed for at least 3 months prior to study entry:
- The subject must have a plasma HIV-1 RNA level less than 200 copies/mL using the AmpliPrep/Taqman HIV-1 Test or Roche Amplicor HIV-1 Monitor Test Version 1.5 Ultrasensitive method at least 3 months prior to the screening visit, as the "qualifying HIV-1 RNA."
- HIV-1 RNA less than 200 copies/mL measured by bDNA (Chiron 3.0) may be used as a qualifying HIV-1 RNA for entry to the study but not for the confirmatory HIV-1 RNA.
- The subject must have a confirmed second plasma HIV-1 RNA less than 200 copies/mL at screening, as the "confirmatory HIV-1 RNA."
- The subject must not have a plasma HIV-1 RNA greater than or equal to 200 copies/mL between the qualifying and confirmatory HIV-1 RNA measurements.
- Subjects receiving lipid-lowering agents (LLA) will be allowed; however, LLAs must be stable for greater than or equal to 3 months prior to study entry.
- +5 more criteria
You may not qualify if:
- Subjects receiving ABC/3TC and a PI without ritonavir
- Subjects receiving other ARV agents (eg, 2 protease inhibitors boosted with low-dose ritonavir (ie, "double-boosted PI regimens"), nonnucleoside reverse transcriptase inhibitors \[NNRTIs\], integrase inhibitors, TDF, or other nucleoside reverse transcriptase inhibitor \[NRTIs\]) in addition to ABC/3TC and a ritonavir-boosted protease inhibitor
- Have known resistance to any of the study agents at any time in the past including NRTI resistance mutations (including but not limited to K65R, L74V/I, M184V/I, or thymidine analog mutations) and/or PI resistance mutations
- A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline
- Previous therapy with agents with systemic myelosuppressive, pancreatoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment
- Proven or suspected acute hepatitis in the 30 days prior to study entry
- Anticipated need to initiate drugs during the study that are contraindicated with protease inhibitors (except upon approval by Gilead)
- Receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
- Nephrotoxic agents (aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, other agents with significant nephrotoxic potential)
- Adefovir dipivoxil
- Probenecid
- Systemic chemotherapeutic agents (ie, cancer treatment medications)
- Systemic corticosteroids
- Interleukin-2 (IL-2)
- Investigational agents (except upon approval by Gilead)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (80)
Health For Life Clinic, PLLC
Little Rock, Arkansas, 72207, United States
Vista Medical Partners
Beverly Hills, California, 90210, United States
AHF
Beverly Hills, California, 90211, United States
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
Center for Special Immunology
Fountain Valley, California, 92708, United States
Living Hope Clinical Foundation
Long Beach, California, 90813, United States
Jeffrey Goodman Special Care Clinic
Los Angeles, California, 90028, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Anthony M Mills, MD
Los Angeles, California, 90069, United States
Orange Coast Medical Group
Newport Beach, California, 92663, United States
Tarzana Treatment Center
Northridge, California, 91324, United States
Alameda County Medical Center
Oakland, California, 94602, United States
Health Management Institute, Inc.
San Francisco, California, 94114, United States
Metropolis Medical
San Francisco, California, 94115, United States
Kaiser Permanente
Denver, Colorado, 80205, United States
Blick Medical Associates
Norwalk, Connecticut, 06851, United States
Biogenomx Research Institute, LLC
Fort Lauderdale, Florida, 33306, United States
Life Way Inc.
Fort Lauderdale, Florida, 33308, United States
Therafirst Medical Centers
Fort Lauderdale, Florida, 33308, United States
HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, 33316, United States
University of Florida
Jacksonville, Florida, 32206, United States
The Kinder Medical Group
Miami, Florida, 33133, United States
University of Miami
Miami, Florida, 33136, United States
South Florida Infectious Diseases and Tropical Medicine Center
Miami, Florida, 33176, United States
Community Health of South Florida Inc.
Miami, Florida, 33190, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, 33139, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Infectious Diseases Associates of NW FL
Pensacola, Florida, 32504, United States
Associates in Infectious Diseases
Port Saint Lucie, Florida, 34952, United States
Barry M. Rodwick, M.D.
Safety Harbor, Florida, 34695, United States
USF Health
Tampa, Florida, 33602, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614, United States
Clinical Pharmacology Services
Tampa, Florida, 33617, United States
Atlanta Infectious Disease Group, PC
Atlanta, Georgia, 30309, United States
Infectious Disease Solutions
Atlanta, Georgia, 30309, United States
Family Healthcare of Atlanta PC
Atlanta, Georgia, 30318, United States
Chatham County Health Department
Savannah, Georgia, 31401, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
NorthStar Medical Center
Chicago, Illinois, 60657, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Chase Brexton Health Services
Baltimore, Maryland, 21201, United States
MetroWest Medical Center
Framingham, Massachusetts, 01702, United States
Community Research Initiative of New England - WEST
Springfield, Massachusetts, 01107, United States
The Research Institute
Springfield, Massachusetts, 01107, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Michigan State University, College of Osteopathic Medicine
East Lansing, Michigan, 48824, United States
St. John Hospital Internal Medicine Clinic - Mack Office Building
Grosse Point Woods, Michigan, 48236, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55145, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55404, United States
ID Associates, PA
Hillsborough, New Jersey, 08844, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
Upstate Infectious Diseases Associates
Albany, New York, 23309, United States
Greiger Clinic
Mount Vernon, New York, 10550, United States
Ricky K. Hsu, MD, PC
New York, New York, 10011, United States
AIDS Community Health Center
Rochester, New York, 14604, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
ID Consultants, P.A.
Charlotte, North Carolina, 28209, United States
East Carolina University The Brody School of Medicine
Greenville, North Carolina, 27858, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Summa Health System Care Center
Akron, Ohio, 44394, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Baylor University Medical Center
Dallas, Texas, 75204, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
North Texas Inf. Disease Consultants
Dallas, Texas, 75246, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104, United States
Valley AIDS Counsel
Harlingen, Texas, 78550, United States
Therapeutic Concepts, PA
Houston, Texas, 77004, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, 77098, United States
Daniel Coulston, MD
Spokane, Washington, 99204, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University of British Columbia
Vancouver, British Columbia, V6Z 2C7, Canada
Canadian Immunodeficiency Research Collaborative Incorporated
Toronto, Ontario, M4J 1V8, Canada
CascAids Research
Toronto, Ontario, M4T 3A7, Canada
Clinique Du Quartier Latin
Montreal, Quebec, H2L5B1, Canada
Instituto de Investigacion Cientifica del Sur
Ponce, 00732, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 00909, Puerto Rico
University of Puerto Rico
San Juan, 00936, Puerto Rico
Related Publications (1)
Campo R, DeJesus E, Bredeek UF, Henry K, Khanlou H, Logue K, Brinson C, Benson P, Dau L, Wang H, White K, Flaherty J, Fralich T, Guyer B, Piontkowsky D. SWIFT: prospective 48-week study to evaluate efficacy and safety of switching to emtricitabine/tenofovir from lamivudine/abacavir in virologically suppressed HIV-1 infected patients on a boosted protease inhibitor containing antiretroviral regimen. Clin Infect Dis. 2013 Jun;56(11):1637-45. doi: 10.1093/cid/cis1203. Epub 2013 Jan 29.
PMID: 23362296DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dara Wambach, MA, Associate Director, Regulatory Affairs
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Todd Fralich, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
May 28, 2012
Results First Posted
April 19, 2012
Record last verified: 2012-05