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

Use our guide to learn which trials are right for you!

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
Costa Mesa, California 92626
2583
mi
from 02139
Costa Mesa, CA
Click here to add this to my saved trials
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...
1052
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
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...
2
mi
from 02139
Boston, MA
Click here to add this to my saved trials
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
1456
mi
from 02139
Longview, TX
Click here to add this to my saved trials
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...
186
mi
from 02139
New York, NY
Click here to add this to my saved trials
4600 N Habana Ave # 23
Tampa, Florida 33614
1181
mi
from 02139
Tampa, FL
Click here to add this to my saved trials
402
mi
from 02139
Annandale, VA
Click here to add this to my saved trials
Atlanta, Georgia 30309
932
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30308
932
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
Berkley, Michigan 48072
615
mi
from 02139
Berkley, MI
Click here to add this to my saved trials
Beverly HIlls, California 90211
2595
mi
from 02139
Beverly HIlls, CA
Click here to add this to my saved trials
Beverly Hills, California 90211
2595
mi
from 02139
Beverly Hills, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28209
721
mi
from 02139
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60612
849
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60657
847
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
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,...
845
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
Columbia, South Carolina 29208
789
mi
from 02139
Columbia, SC
Click here to add this to my saved trials
Dallas, Texas 75204
1545
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
929
mi
from 02139
Decatur, GA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
1234
mi
from 02139
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Pierce, Florida 34982
1157
mi
from 02139
Fort Pierce, FL
Click here to add this to my saved trials
1574
mi
from 02139
Fort Worth, TX
Click here to add this to my saved trials
Harlingen, Texas 78550
1871
mi
from 02139
Harlingen, TX
Click here to add this to my saved trials
Hayward, California 94545
2679
mi
from 02139
Hayward, CA
Click here to add this to my saved trials
Houston, Texas 77098
1605
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77004
1603
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77098
1605
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
710
mi
from 02139
Huntersville, NC
Click here to add this to my saved trials
Kansas City, Missouri 64111
1245
mi
from 02139
Kansas City, MO
Click here to add this to my saved trials
Little Rock, Arkansas 72207
1257
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90813
2594
mi
from 02139
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90028
2591
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90059
2592
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90036
2593
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90027
2588
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90069
2594
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Lutherville, Maryland 21093
352
mi
from 02139
Lutherville, MD
Click here to add this to my saved trials
Miami, Florida 33133
1260
mi
from 02139
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33137
1253
mi
from 02139
Miami, FL
Click here to add this to my saved trials
Miami Beach, Florida 33139
1255
mi
from 02139
Miami Beach, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55414
1116
mi
from 02139
Minneapolis, MN
Click here to add this to my saved trials
Mt Vernon, New York
173
mi
from 02139
Mt Vernon, NY
Click here to add this to my saved trials
New York, New York 10016
185
mi
from 02139
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07102
194
mi
from 02139
Newark, NJ
Click here to add this to my saved trials
Newport Beach, California 92663
2586
mi
from 02139
Newport Beach, CA
Click here to add this to my saved trials
Oakland, California 94609
2680
mi
from 02139
Oakland, CA
Click here to add this to my saved trials
Oakland, California 94602
2679
mi
from 02139
Oakland, CA
Click here to add this to my saved trials
1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
1112
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32806
1115
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
2687
mi
from 02139
Palo Alto, CA
Click here to add this to my saved trials
Pensacola, Florida 32504
1209
mi
from 02139
Pensacola, FL
Click here to add this to my saved trials
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...
270
mi
from 02139
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
268
mi
from 02139
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
2290
mi
from 02139
Phoenix, AZ
Click here to add this to my saved trials
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...
2622
mi
from 02139
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95825
2617
mi
from 02139
Sacramento, CA
Click here to add this to my saved trials
Safety Harbor, Florida 34695
1186
mi
from 02139
Safety Harbor, FL
Click here to add this to my saved trials
?
mi
from 02139
Salzberg,
Click here to add this to my saved trials
San Diego, California 92103
2575
mi
from 02139
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94115
2691
mi
from 02139
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94115
2691
mi
from 02139
San Francisco, CA
Click here to add this to my saved trials
Somer Point, New Jersey 08244
278
mi
from 02139
Somer Point, NJ
Click here to add this to my saved trials
Springfield, Massachusetts 01107
78
mi
from 02139
Springfield, MA
Click here to add this to my saved trials
St. Louis, Missouri 63139
1038
mi
from 02139
St. Louis, MO
Click here to add this to my saved trials
1225
mi
from 02139
Tampa, FL
Click here to add this to my saved trials
Washington, District of Columbia 20036
392
mi
from 02139
Washington,
Click here to add this to my saved trials
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...
654
mi
from 02139
Winston-Salem, NC
Click here to add this to my saved trials