Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Philadelphia Fight
• Collaborator: Gilead Sciences
• Treatments: Tenofovir

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