Safety and Efficacy Study of Switching From Epzicom to Truvada (SWIFT)
HIV Infection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV, HIV 1
Eligibility Criteria
Inclusion Criteria:
- 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.
- Adequate renal function defined as a calculated CLcr greater than or equal to 50 mL/min according to the Cockcroft-Gault formula
- Negative serum pregnancy test (females of childbearing potential only)
- Hepatic transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 5 X upper limit of normal
- Males and females (of childbearing potential, ie, a non-menopausal female or a female with menopause < 2 years, and who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure; this definition includes a young woman who has not yet started menstruating), and must agree to avoid pregnancy by sexual abstinence, or utilization of a highly effective method of birth control throughout the study period and for 30 days following discontinuation of study drug
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
Exclusion Criteria:
- 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)
- Pregnant or lactating subjects
- Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject adherence
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study.
- Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial therapy within 15 days prior to screening
- Prior history of significant renal or bone disease
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
- Known hypersensitivity to the study drugs, the metabolites or formulation excipients
Sites / Locations
- Health For Life Clinic, PLLC
- Vista Medical Partners
- AHF
- Pacific Oaks Medical Group
- Center for Special Immunology
- Living Hope Clinical Foundation
- Jeffrey Goodman Special Care Clinic
- Peter J. Ruane, MD, Inc.
- Anthony M Mills, MD
- Orange Coast Medical Group
- Tarzana Treatment Center
- Alameda County Medical Center
- Health Management Institute, Inc.
- Metropolis Medical
- Kaiser Permanente
- Blick Medical Associates
- Life Way Inc.
- Therafirst Medical Centers
- Gary Richmond, MD, PA, Inc.
- Biogenomx Research Institute, LLC
- HIV Clinical Research
- University of Florida
- Wohlfeiler, Piperato and Associates, LLC
- The Kinder Medical Group
- University of Miami
- South Florida Infectious Diseases and Tropical Medicine Center
- Community Health of South Florida Inc.
- Orlando Immunology Center
- Infectious Diseases Associates of NW FL
- Associates in Infectious Diseases
- Barry M. Rodwick, M.D.
- USF Health
- Infectious Disease Research Institute, Inc.
- Clinical Pharmacology Services
- Atlanta Infectious Disease Group, PC
- Infectious Disease Solutions
- Family Healthcare of Atlanta PC
- Chatham County Health Department
- Howard Brown Health Center
- NorthStar Medical Center
- University of Louisville
- Chase Brexton Health Services
- MetroWest Medical Center
- Community Research Initiative of New England - WEST
- The Research Institute
- Be Well Medical Center
- Henry Ford Hospital
- Michigan State University, College of Osteopathic Medicine
- St. John Hospital Internal Medicine Clinic - Mack Office Building
- Hennepin County Medical Center
- Abbott Northwestern Hospital
- ID Associates, PA
- Saint Michael's Medical Center
- South Jersey Infectious Disease
- Upstate Infectious Diseases Associates
- Greiger Clinic
- Ricky K. Hsu, MD, PC
- AIDS Community Health Center
- University of Rochester Medical Center
- ID Consultants, P.A.
- East Carolina University The Brody School of Medicine
- Wake Forest University School of Medicine
- Summa Health System Care Center
- Central Texas Clinical Research
- Baylor University Medical Center
- UT Southwestern Medical Center at Dallas
- North Texas Inf. Disease Consultants
- Tarrant County Infectious Disease Associates
- Valley AIDS Counsel
- Therapeutic Concepts, PA
- Gordon E. Crofoot, MD, PA
- Daniel Coulston, MD
- Medical College of Wisconsin
- University of British Columbia
- Canadian Immunodeficiency Research Collaborative Incorporated
- CascAids Research
- Clinique Du Quartier Latin
- Instituto de Investigacion Cientifica del Sur
- Clinical Research Puerto Rico Inc
- University of Puerto Rico
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
FTC/TDF (Truvada [TVD]) + PI/r
ABC/3TC + PI/r
Participants 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.
Participants 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.