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 |
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.
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
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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Annandale, Virginia 22003
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of California-Davis As we begin our second century, UC Davis is poised to become...
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