Phase 4
N=37
Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide
Hiv
Bottom Line
View on ClinicalTrials.gov: NCT03350672 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). — 100; 80; 80; 80 percentage of urine samples
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FTC/TAF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philadelphia Fight
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). |
100; 80; 80; 80; 30; 30 | — |
| PRIMARY Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). |
60; 60; 30; 20; 0; 0 | — |
| PRIMARY Percentage of Urine Samples Containing Tenofovir at Concentrations Greater Than or Equal to 1000ng/mL (Cohort 2). |
100 | — |
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 maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been validated in several large international trials that have included men who have sex with men and transgender women, heterosexual men and women, and people who use injection drugs, as a potential HIV-1 prevention strategy. HIV prevention interventions such as this, if adequately disseminated and implemented broadly, may help to curb new HIV infections, reduce HIV-associated morbidity and mortality, and reduce health disparities in HIV rates among the most at-risk individuals. Assuring adherence to a daily dose of PrEP is critical for effective protection against HIV infection. A urine-based test to measure PrEP medication levels in the body represents a non-invasive technique to assess adherence and ultimately improve PrEP's protective ability.
TAF/FTC (Descovy™) is a new medication under study for HIV prevention to see if it is as effective as Truvada™. This study is testing whether a urine test can detect this medication in urine.
Eligibility Criteria
Cohort 1(a & b) Inclusion Criteria:
- 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 Criteria:
- 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 Exclusion Criteria:
- 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)
- Grade 3 laboratory abnormality on screening tests/assessments as defined by the DAIDS grading system
- 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
Data sourced from ClinicalTrials.gov (NCT03350672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.