The Cellular Pharmacology of F-TAF in Dried Blood Spots

Exclusion Criteria

• •1. Inability to give informed consent
• •2. Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
• •3. Current breastfeeding
• •4. High risk of HIV-1 infection, for example:
• •* sexually active with an HIV infected partner;
• •* men who have sex with men who may engage in condomless intercourse with HIVinfected partners, or
• •* partner of unknown status during the study;
• •* males or females who exchange sex for money, shelter, or gifts;
• •* active injection drug use or during the last 12 months;
• •* newly diagnosed sexually transmitted infections in last 6 months
• •5. 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:
• •* fever,
• •* headache,
• •* fatigue,
• •* arthralgia,
• •* vomiting,
• •* myalgia, .
• •* diarrhea,
• •* pharyngitis,
• •* rash,
• •* night sweats, and
• •* adenopathy (cervical or inguinal)
• •6. Positive Hepatitis B Virus (HBV) surface antigen test at screening
• •7. Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
• •8. Glomerular Filtration Rate (GFR) estimate \< 60 ml/min (MDRD equation).
• •9. Urine dipstick protein ≥ 2+
• •10. Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
• •11. Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
• •12. Symptomatic hemoglobinopathies or active hemolysis.
• •13. History of pathological, non-traumatic bone fractures
• •14. 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.
• •15. Prohibited concomitant medications are:
• •* investigational agents (within 30 days of enrollment),
• •* aminoglycosides,
• •* ganciclovir/valganciclovir,
• •* chronic high-dose acyclovir/valacyclovir (\>800mg acyclovir or \> 500mg valacyclovir for 7 days),
• •* cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TRUVADA®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.