Status:
COMPLETED
Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide
Lead Sponsor:
Philadelphia Fight
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hiv
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications (one pill daily) to mai...
Detailed Description
Primary Objectives: 1a) To determine how long TFV is excreted in the urine in patients at steady state of TAF/FTC. Ten healthy subjects will be given seven daily doses of TAF/FTC under direct observa...
Eligibility Criteria
Inclusion
- Cohort 1(a \& b)
- Age 18 or older at the time of signed informed consent
- Not currently taking commercial Truvada for PrEP or any other investigational, oral medication for the purpose of HIV PrEP
- Willing and able to independently provide written informed consent
- Tests HIV negative at time of screening using rapid HIV antibody test or serum antibody/antigen 4th generation HIV test
- Cohort 1(a \& b)
Exclusion
- Evidence of acute or chronic hepatitis B infection at the time of screening
- Other clinically significant acute or chronic medical condition, including severe infections requiring treatment such as tuberculosis, as determined by the study investigator
- Evidence of renal dysfunction (Creatinine Clearance \< 30 ml/min) at the time of screening; Use Cockroft-Gault equation: GFR = (140-Age in years) x (Weight in kg) / (72 x serum creatinine)
- History of bone fractures not explained by trauma
- Grade 3 laboratory abnormality on screening tests/assessments as defined by the DAIDS grading system
- Known allergy/sensitivity to the study drug or its components
- Experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
- Any other clinical condition or prior therapy that, in the opinion of the Principal Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
- Cohort 2 Inclusion Criteria:
- Age 18 or older at the time of signed informed consent
- Willing and able to independently provide written informed consent
- Last viral load \< 20 copies/mL within the last four weeks of screening
- Must be on combination antiretroviral therapy that includes TAF/FTC for at least 6 months
- Undetectable viral load, as defined by \< 50 copies/ml, for at least 6 months
- Cohort 2
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03350672
Start Date
November 16 2017
End Date
May 1 2018
Last Update
September 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107