Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
Status: | Active, not recruiting |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/21/2018 |
Start Date: | June 29, 2015 |
End Date: | March 2019 |
A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to
emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human
immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on
regimens containing ABC/3TC.
of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to
emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human
immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on
regimens containing ABC/3TC.
Key Inclusion Criteria:
- The ability to understand and sign a written informed consent form
- On antiretroviral regimen containing ABC/3TC FDC in combination with one third agent
for ≥ 6 consecutive months prior to screening
- Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit
(measured at least twice using the same assay) and without experiencing two
consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two
consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
- Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit
- Normal ECG
- Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft
Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Males and females of childbearing potential must agree to utilize highly effective
contraception methods or be non-heterosexually active or practice sexual abstinence
from screening throughout the duration of study treatment and for 30 days following
the last dose of study drug
Key Exclusion Criteria:
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Individuals experiencing decompensated cirrhosis
- Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg,
osteoporosis)
- Pregnant or lactating females
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the investigator to potentially interfere
with 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.
- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
- 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
- Medications excluded due to the potential for interaction with emtricitabine (FTC),
TAF, ABC or 3TC
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
35
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Louisville The University of Louisville is a state supported research university located in...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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