Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:October 2014

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A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is
to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil
fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or
fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor
(PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically
suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment
option to patients who wish to simplify dosing by reducing pill burden or to improve the
tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which
participants will switch treatment regimens at the start of the study, and the Stay on
Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their
baseline regimen during the first 24 weeks of the study (designed to provide an initial
active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the
FTC/RPV/TDF STR per protocol before switching to a commercially available source.


Inclusion Criteria:

- Ability to understand and sign a written informed consent form

- Receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs
continuously for ≥ 6 months preceding the screening visit

- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
for ≥ 6 months prior to the screening visit and HIV-1 RNA < 50 copies/mL at the
screening visit

- On their first or second antiretroviral drug regimen; if on their second regimen,
HIV-1 RNA ≤ 50 copies/mL required at the time of the first change in antiretroviral
drugs, and no HIV RNA > 50 copies/mL measured at two consecutive time points after
first achieving HIV RNA < 50 copies/mL

- No previous use of any approved or experimental nonnucleoside reverse transcriptase
inhibitor (NNRTI) drug for any length of time

- Have a genotype prior to starting initial antiretroviral therapy and no known
resistance to any of the study agents

- Normal ECG

- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥
50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

- Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serum
lipase ≤ 5 x ULN)

- Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according
to the Cockcroft-Gault formula)

- Males and females of childbearing potential must agree to utilize highly effective
contraception methods (two separate forms of contraception, one of which must have
been an effective barrier method, or been nonheterosexually active, practice sexual
abstinence, or have a vasectomized partner) from screening throughout the duration of
the study period and for 30 days following the last dose of study drug.

- Age ≥ 18 years

- Life expectancy ≥ 1 year

Exclusion Criteria:

- A new AIDS-defining condition diagnosed within 30 days prior to screening except
cluster of differentiation 4 (CD4) cell count and/or percentage criteria

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Proven or suspected acute hepatitis 30 days prior to study entry.

- Current alcohol or substance abuse judged by the Investigator to potentially
interfere with subject compliance.

- History of malignancy within 5 years prior to study entry or ongoing malignancy other
than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive
cutaneous squamous carcinoma

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

- Anticipated need to initiate contraindicated drugs during the study, including drugs
not to be used with FTC, TDF, RPV; or subjects with known allergies to the excipients
of FTC/RPV/TDF STR tablets or Truvada® tablets

- All investigational drugs

- Medications and use of herbal/natural supplements excluded or to be used with caution
while participating in the study, including those not to be taken with Viread®,
Emtriva®, Truvada, and Rilpivirine.

- Participation in any other clinical trial without prior approval from the sponsor was
prohibited while participating in this trial

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

- History of liver disease, including Gilbert's Disease

- Any other clinical condition or prior therapy making the subject unsuitable for the
study or unable to comply with the dosing requirements
We found this trial at
67
sites
Houston, Texas 77004
1892
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Houston, TX
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
2072
mi
from 98109
Birmingham, AL
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
2485
mi
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Boston, MA
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
1778
mi
from 98109
Longview, TX
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
2402
mi
from 98109
New York, NY
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4600 N Habana Ave # 23
Tampa, Florida 33614
2523
mi
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Tampa, FL
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2316
mi
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Annandale, VA
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Atlanta, Georgia 30309
2177
mi
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Atlanta, GA
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Atlanta, Georgia 30308
2178
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Atlanta, GA
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Berkley, Michigan 48072
1922
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Berkley, MI
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Beverly HIlls, California 90211
959
mi
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Beverly HIlls, CA
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Beverly Hills, California 90211
959
mi
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Beverly Hills, CA
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Charlotte, North Carolina 28209
2282
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Charlotte, NC
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Chicago, Illinois 60612
1730
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Chicago, IL
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Chicago, Illinois 60657
1730
mi
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Chicago, IL
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
1732
mi
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Chicago, IL
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Columbia, South Carolina 29208
2322
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Columbia, SC
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Costa Mesa, California 92626
991
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Costa Mesa, CA
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Dallas, Texas 75204
1680
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Dallas, TX
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2182
mi
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Decatur, GA
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Fort Lauderdale, Florida 33316
2718
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Fort Lauderdale, FL
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Fort Pierce, Florida 34982
2648
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Fort Pierce, FL
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1661
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Fort Worth, TX
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Harlingen, Texas 78550
1994
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Harlingen, TX
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Hayward, California 94545
692
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Hayward, CA
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Houston, Texas 77098
1890
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Houston, TX
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Houston, Texas 77098
1890
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Houston, TX
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Huntersville, North Carolina 28078
2273
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Huntersville, NC
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Kansas City, Missouri 64111
1503
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Kansas City, MO
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Little Rock, Arkansas 72207
1778
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Little Rock, AR
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Long Beach, California 90813
981
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Long Beach, CA
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Los Angeles, California 90028
958
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Los Angeles, CA
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Los Angeles, California 90059
970
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Los Angeles, CA
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Los Angeles, California 90036
959
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Los Angeles, California 90027
956
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Los Angeles, CA
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Los Angeles, California 90069
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Los Angeles, CA
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Lutherville, Maryland 21093
2321
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Lutherville, MD
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Miami, Florida 33133
2731
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Miami, FL
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Miami, Florida 33137
2730
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Miami, FL
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Miami Beach, Florida 33139
2733
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Miami Beach, FL
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Minneapolis, Minnesota 55414
1393
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Minneapolis, MN
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Mt Vernon, New York
2403
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Mt Vernon, NY
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New York, New York 10016
2402
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Newark, New Jersey 07102
2393
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Newark, NJ
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Newport Beach, California 92663
995
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Oakland, California 94609
677
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Oakland, CA
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Oakland, California 94602
679
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Oakland, CA
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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...
2547
mi
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Orlando, FL
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Orlando, Florida 32806
2549
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Orlando, FL
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Palo Alto, California 94304
704
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Palo Alto, CA
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Pensacola, Florida 32504
2198
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Pensacola, FL
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
2371
mi
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Philadelphia, PA
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Philadelphia, Pennsylvania 19107
2373
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Philadelphia, PA
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Phoenix, Arizona 85012
1112
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
627
mi
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Sacramento, CA
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Sacramento, California 95825
626
mi
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Sacramento, CA
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Safety Harbor, Florida 34695
2514
mi
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Safety Harbor, FL
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Salzberg,
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San Diego, California 92103
1063
mi
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San Diego, CA
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San Francisco, California 94115
680
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San Francisco, CA
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San Francisco, California 94115
680
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San Francisco, CA
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Somer Point, New Jersey 08244
2421
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Somer Point, NJ
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Springfield, Massachusetts 01107
2423
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Springfield, MA
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St. Louis, Missouri 63139
1717
mi
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St. Louis, MO
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2713
mi
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Tampa, FL
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Washington, District of Columbia 20036
2322
mi
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Washington,
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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...
2279
mi
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Winston-Salem, NC
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