Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2011
End Date:December 2014

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A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

This study will evaluate the noninferiority of Stribild®
(elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF))
single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse
transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50
copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will
also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of
treatment.


Inclusion Criteria:

- Ability to understand and sign a written informed consent form

- Be stable on the current formulation(s) of an antiretroviral regimen consisting of an
NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This
includes those who began a regimen with individual drug components and subsequently
simplified to include a fixed-dose combination formulation of the same drugs.

- Be on the first or second antiretroviral regimen with documented undetectable plasma
HIV 1 RNA levels for ≥ 6 months preceding the screening visit

- No previous use of any approved or experimental integrase strand transfer inhibitor
(INSTI) for any length of time

- Documented historical genotype prior to starting initial antiretroviral therapy
showing no known resistance to TDF or FTC

- HIV RNA < 50 copies/mL at screening

- Normal ECG

- Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)

- Total bilirubin ≤ 1.5 mg/dL

- Adequate hematologic function

- Serum amylase ≤ 5 × ULN

- Estimated glomerular filtration rate ≥ 70 mL/min

- Females of childbearing potential must agree to utilize protocol recommended
contraception methods or be nonheterosexually active, practice sexual abstinence from
screening throughout the duration of the study period and for 12 weeks for
participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants
following the last dose of study drug

- Female participants who utilize hormonal contraceptive as one of their birth control
methods must have used the same method for at least three months prior to study
dosing

- Male participants must agree to utilize protocol-recommended methods of contraception
during heterosexual intercourse or be nonheterosexually active, and practice sexual
abstinence from the screening visit.

- Age ≥ 18 years

Exclusion Criteria:

- New AIDS-defining condition diagnosed within the 30 days prior to screening

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Receiving drug treatment for hepatitis C, or those who are anticipated to receive
treatment for hepatitis C during the course of the study

- Experiencing decompensated cirrhosis

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance abuse that would interfere with compliance

- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, noninvasive
cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not
have received any systemic therapy for KS within 30 days of baseline and must not be
anticipated to require systemic therapy during the study.

- Active, serious infections requiring parenteral antibiotic or antifungal therapy
within 30 days prior to baseline

- Have been treated with immunosuppressant therapies or chemotherapeutic agents within
3 months of study screening, or expected to receive these agents or systemic steroids
during the study

- Receiving ongoing therapy with any of the medications, including drugs not to be used
with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the
excipients of E/C/F/TDF tablets, or FTC/TDF tablets

- No anticipated need to initiate drugs during the study that are contraindicated

- Receiving other investigational drugs

- Participation in any other clinical trial

- Any other clinical condition or prior therapy that would make the participant
unsuitable for the study or unable to comply with the dosing requirements
We found this trial at
40
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Atlanta, Georgia 30309
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Berkley, Michigan 48072
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Beverly Hills, California 90211
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Beverly Hills, California 90211
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Charlotte, North Carolina 28209
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Darlinghurst,
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Decatur, GA
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Fort Lauderdale, Florida 33316
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Fort Pierce, Florida 34982
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Hayward, California 94545
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Hillsborough, New Jersey 08844
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Houston, Texas 77098
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Houston, Texas 77004
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Kansas City, Missouri 64111
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Los Angeles, California 90069
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Los Angeles, California 90036
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Los Angeles, California 90059
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Miami, Florida 33133
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Minneapolis, Minnesota 55415
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Mt. Vernon, New York 10550
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New York, New York 10016
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Newark, New Jersey 07102
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Oakland, California 94602
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19107
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Phoenix, Arizona 85012
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Sacramento, California 95825
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Safety Harbor, Florida 34684
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San Diego, California 92103
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San Francisco, California 94115
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San Francisco, California 94115
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Somers Point, New Jersey 08244
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Washington, District of Columbia 20036
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Washington, District of Columbia 20009
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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