Expired Study
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Beverly Hills, California 90211


Purpose:

This protocol describes a prospective, randomized, open label, multi center study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose tenofovir DF (TDF)/emtricitabine (FTC) in virologically suppressed, HIV 1 infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r) containing antiretroviral regimen. Duration of treatment is 48 weeks.


Study summary:

This protocol describes a prospective, randomized, open label, multi center study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose tenofovir DF (TDF)/emtricitabine (FTC) in virologically suppressed, HIV 1 infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r) containing antiretroviral regimen. Duration of treatment is 48 weeks.


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 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 PCR or 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." - Viral load 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 creatinine clearance (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 (AST and ALT) less than 5 X upper limit of normal (ULN) - Males and females (of childbearing potential, i.e., 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) 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 antiretroviral agents (e.g., 2 protease inhibitors boosted with low-dose ritonavir (i.e., "double-boosted PI regimens"), NNRTSs, integrase inhibitors, TDF, or other NRTIs) in addition to ABC/3TC and ritonavir-boosted PI. - 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 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, IV pentamidine, other agents with significant nephrotoxic potential) - Adefovir dipivoxil - Probenecid - Systemic chemotherapeutic agents (i.e., 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.


Study is Available At:


Original ID:

GS-US-164-0216


NCT ID:

NCT00724711


Secondary ID:


Study Acronym:

SWIFT


Brief Title:

Safety and Efficacy Study of Switching From Epzicom to Truvada


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 Maintaine


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gilead Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

312


Enrollment Type:

Actual


Overall Contact Information

Official Name:Todd Fralich, MD
Study Director
Gilead Sciences

Study Dates

Start Date:July 2008
Completion Date:April 2011
Completion Type:Actual
Primary Completion Date:April 2011
Primary Completion Type:Actual
Verification Date:November 2011
Last Changed Date:November 11, 2011
First Received Date:July 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:To determine the proportion of subjects who maintain HIV 1 RNA <200 copies/mL through Week 48.
Time Frame:48 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To describe the safety and tolerability of each treatment arm over 48 weeks.
Time Frame:48 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To assess change from baseline in glomerular filtration rate (GFR) as estimated by both calculated creatinine clearance using the Cockcroft Gault (C-G) method, and by the abbreviated Modified Diet in Renal Disease (MDRD) method.
Time Frame:48 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To compare change from baseline in fasting lipid parameters (triglycerides, total cholesterol, LDL- and HDL cholesterol and total cholesterol/HDL ratio) over 48 weeks.
Time Frame:48 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To assess change from baseline in CD4 cell count in each arm at 48 weeks.
Time Frame:48 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To explore changes from baseline in certain cardiovascular biomarkers,over 48 weeks, in a sub-set of subjects.
Time Frame:48 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:tenofovir/emtricitabine
Description:TDF 300 mg/FTC 200 mg tablet, once a day
Arm Name:1
Other Name:Truvada
Intervention Type:Drug
Name:Abacavir(ABC)/Lamivudine(3TC)
Description:ABC 600 mg/3TC 300 mg tablet, once a day
Arm Name:2
Other Name:Epzicom

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Patients in this arm will switch to the fixed-dose combination TDF 300 mg/FTC 200 mg (Truvada) administered as one tablet orally, once daily QD),for 48 weeks. The patient's pre-study ritonavir-boosted PI will be continued unmodified through the 48 weeks of the study.
Study Arm Type:Active Comparator
Arm Name:2
Description:Subjects in this arm will continue their pre-study 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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Gilead Sciences

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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