Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
Status: | Completed |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/8/2019 |
Start Date: | January 26, 2015 |
End Date: | January 2, 2019 |
A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects
The primary objective of this study is to evaluate the non-inferiority of switching to
emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as
compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of
efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed
HIV-1 infected participants.
emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as
compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of
efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed
HIV-1 infected participants.
Key Inclusion Criteria:
- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
- Currently receiving EFV/FTC/TDF FDC for ≥ 6 consecutive months preceding the screening
visit
- Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level
according to the local assay being used if the limit of detection is > 50 copies/mL)
for ≥ 6 months preceding the screening visit. Unconfirmed virologic elevation of ≥ 50
copies/mL after previously reaching viral suppression (transient detectable viremia,
or "blip") and prior to screening is acceptable
- Have no documented resistance to any of the study agents at any time in the past
- HIV-1 RNA < 50 copies/mL at the screening visit
- Hepatic transaminases (AST and ALT) ≤ 5 × 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 × ULN (individuals with serum amylase > 5 × ULN will remain eligible
if serum lipase is ≤ 5 × ULN)
- Normal ECG (or if abnormal, determined by the Investigator to be not clinically
significant)
- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min according to
the Cockcroft-Gault formula
Key Exclusion Criteria:
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals
who have HCV antibody but no detectable HCV RNA are eligible to enroll)
- Individuals experiencing or with a medical history of decompensated cirrhosis (e.g.,
ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Current alcohol or substance use judged by the Investigator to potentially interfere
with the individual's study compliance
- A history of malignancy within the past 5 years (prior to screening) or ongoing
malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or
resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are
eligible, but must not have received any systemic therapy for KS within 30 days of
Baseline/Day 1 and must not be anticipated to require systemic therapy during the
study
- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1
- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the individual unsuitable for the study or unable to comply
with dosing requirements
- Participation in any other clinical trial (including observational trials) without
prior approval from the sponsor is prohibited while participating in this trial
- Individuals receiving ongoing therapy with any of the following medications in the
table below, including drugs not to be used with FTC, RPV and/or TAF (refer to the
individual agents Prescribing Information); or individuals with any known allergies to
the excipients of FTC/RPV/TAF
Note: Other protocol defined inclusion/exclusion criteria may apply.
We found this trial at
80
sites
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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University of Miami A private research university with more than 15,000 students from around the...
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Annandale, Virginia 22003
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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351 West Jefferson Boulevard
Fort Worth, Texas 76104
Fort Worth, Texas 76104
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Indiana University Medical Center Indiana University Health is Indiana
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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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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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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