Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Status: | Completed |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/1/2019 |
Start Date: | January 26, 2015 |
End Date: | January 9, 2019 |
A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
The primary objective of this study is to evaluate the noninferiority of switching to
emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC)
as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in
virologically suppressed HIV-1 infected participants.
emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC)
as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) 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 FTC/RPV/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. After reaching HIV-1 RNA < 50 copies/mL,
single values of HIV-1 RNA ≥ 50 copies/mL followed by resuppression, are allowed
- 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 (≤ 26 μmol/L), or normal direct bilirubin
- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3 (1.00 GI/L);
platelets ≥ 50,000/mm^3 (50 GI/L); hemoglobin ≥ 8.5 g/dL (85 g/L))
- 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 (1.17
mL/sec) 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 subject 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 subject 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 Inclusion/Exclusion criteria may apply.
We found this trial at
77
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Annandale, Virginia 22003
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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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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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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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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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