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HIV InfectionPhase 4SWIFTNCT00724711

Safety and Efficacy Study of Switching From Epzicom to Truvada

A Phase 4 study testing emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) and abacavir (ABC)/lamivudine (3TC) in people with HIV Infection, run by Gilead Sciences at 80 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) and abacavir (ABC)/lamivudine (3TC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
80 sitesin 3 countries
Study dates
Jul 2008to Apr 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

80 sites in 3 countries.

80 sites in 3 countries

United States73 sites

  • Summa Health System Care Center

    Akron, Ohio, 44394

  • Upstate Infectious Diseases Associates

    Albany, New York, 23309

  • Atlanta Infectious Disease Group, PC

    Atlanta, Georgia, 30309

  • Infectious Disease Solutions

    Atlanta, Georgia, 30309

  • Family Healthcare of Atlanta PC

    Atlanta, Georgia, 30318

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Chase Brexton Health Services

    Baltimore, Maryland, 21201

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • Vista Medical Partners

    Beverly Hills, California, 90210

  • AHF

    Beverly Hills, California, 90211

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • ID Consultants, P.A.

    Charlotte, North Carolina, 28209

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • NorthStar Medical Center

    Chicago, Illinois, 60657

  • Baylor University Medical Center

    Dallas, Texas, 75204

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

  • North Texas Inf. Disease Consultants

    Dallas, Texas, 75246

  • Kaiser Permanente

    Denver, Colorado, 80205

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Michigan State University, College of Osteopathic Medicine

    East Lansing, Michigan, 48824

  • Biogenomx Research Institute, LLC

    Fort Lauderdale, Florida, 33306

  • Life Way Inc.

    Fort Lauderdale, Florida, 33308

  • Therafirst Medical Centers

    Fort Lauderdale, Florida, 33308

  • HIV Clinical Research

    Fort Lauderdale, Florida, 33311

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Center for Special Immunology

    Fountain Valley, California, 92708

  • MetroWest Medical Center

    Framingham, Massachusetts, 01702

  • East Carolina University The Brody School of Medicine

    Greenville, North Carolina, 27858

  • St. John Hospital Internal Medicine Clinic - Mack Office Building

    Grosse Point Woods, Michigan, 48236

  • Valley AIDS Counsel

    Harlingen, Texas, 78550

  • ID Associates, PA

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot, MD, PA

    Houston, Texas, 77098

  • University of Florida

    Jacksonville, Florida, 32206

  • Health For Life Clinic, PLLC

    Little Rock, Arkansas, 72207

  • Living Hope Clinical Foundation

    Long Beach, California, 90813

  • Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Anthony M Mills, MD

    Los Angeles, California, 90069

  • University of Louisville

    Louisville, Kentucky, 40202

  • The Kinder Medical Group

    Miami, Florida, 33133

  • University of Miami

    Miami, Florida, 33136

  • South Florida Infectious Diseases and Tropical Medicine Center

    Miami, Florida, 33176

  • Community Health of South Florida Inc.

    Miami, Florida, 33190

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55145

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55404

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Ricky K. Hsu, MD, PC

    New York, New York, 10011

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Tarzana Treatment Center

    Northridge, California, 91324

  • Blick Medical Associates

    Norwalk, Connecticut, 06851

  • Alameda County Medical Center

    Oakland, California, 94602

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Infectious Diseases Associates of NW FL

    Pensacola, Florida, 32504

  • Associates in Infectious Diseases

    Port Saint Lucie, Florida, 34952

  • AIDS Community Health Center

    Rochester, New York, 14604

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Barry M. Rodwick, M.D.

    Safety Harbor, Florida, 34695

  • Health Management Institute, Inc.

    San Francisco, California, 94114

  • Metropolis Medical

    San Francisco, California, 94115

  • Chatham County Health Department

    Savannah, Georgia, 31401

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Daniel Coulston, MD

    Spokane, Washington, 99204

  • Community Research Initiative of New England - WEST

    Springfield, Massachusetts, 01107

  • The Research Institute

    Springfield, Massachusetts, 01107

  • USF Health

    Tampa, Florida, 33602

  • Infectious Disease Research Institute, Inc.

    Tampa, Florida, 33614

  • Clinical Pharmacology Services

    Tampa, Florida, 33617

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada4 sites

  • Clinique Du Quartier Latin

    Montreal, Quebec, H2L5B1

  • Canadian Immunodeficiency Research Collaborative Incorporated

    Toronto, Ontario, M4J 1V8

  • CascAids Research

    Toronto, Ontario, M4T 3A7

  • University of British Columbia

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Puerto Rico3 sites

  • Instituto de Investigacion Cientifica del Sur

    Ponce, 00732

  • Clinical Research Puerto Rico Inc

    San Juan, 00909

  • University of Puerto Rico

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: 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 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.

Read the detailed description

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.

Conditions
HIV Infection
Being tested
emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), abacavir (ABC)/lamivudine (3TC)
Keywords
HIV, HIV 1
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)Drug

    Also called Truvada

    FTC 200 mg/TDF 300 mg tablet, once a day

  • abacavir (ABC)/lamivudine (3TC)Drug

    Also called Epzicom, Kivexa

    ABC 600 mg/3TC 300 mg tablet, once a day

Study groups in NCT00724711
Study groupRoleWhat they receive
FTC/TDF (Truvada [TVD]) + PI/rExperimentalParticipants 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.
Receives: Drug: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
ABC/3TC + PI/rActive 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.
Receives: Drug: abacavir (ABC)/lamivudine (3TC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 48 weeks

Secondary outcomes (13)

  1. Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48

    The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.

    Measured: Baseline to 48 weeks

  2. Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48

    The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.

    Measured: Baseline to 48 weeks

  3. Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48

    The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.

    Measured: 48 weeks

  4. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.

    Measured: 48 weeks

  5. Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  6. Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  7. Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  8. Change From Baseline Fasting Glucose at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  9. Change From Baseline Fasting Lipid Parameters at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  10. Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  11. Change From Baseline C-Reactive Protein at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  12. Change From Baseline Fibrinogen at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

  13. Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48

    Change = Week 48 value minus baseline value

    Measured: Baseline to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00724711
Sponsor's protocol ID
GS-US-164-0216
Acronym
SWIFT
Status last verified
May 2012
First submitted
25 Jul 2008
Last updated
28 May 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 23362296

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) and abacavir (ABC)/lamivudine (3TC) in people with HIV Infection, run by Gilead Sciences at 80 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline to 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00724711, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.

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