Status and phase
Conditions
Treatments
About
Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide (F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood cells and dried blood spots, the study plans to see if these results predict adherence to taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence. Investigators will also measure drug in hair clippings to see if hair or DBS are a better predictor of adherence.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Inability to give informed consent
Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
Current breastfeeding
High risk of HIV-1 infection, for example:
Positive screening HIV+ ELISA or suspected acute HIV infection in the opinion of the clinician. Example signs and symptoms of acute HIV infection include combinations of:
Positive Hepatitis B Virus (HBV) surface antigen test at screening
Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
Glomerular Filtration Rate (GFR) estimate < 60 ml/min (MDRD equation).
Urine dipstick protein ≥ 2+
Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
Symptomatic hemoglobinopathies or active hemolysis.
History of pathological, non-traumatic bone fractures
Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.
Prohibited concomitant medications are:
Primary purpose
Allocation
Interventional model
Masking
38 participants in 6 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal