The Cellular Pharmacology of F-TAF in Dried Blood Spots

Inclusion criteria

• Ambulatory 18-59 year old adults. Enrollment will proceed without the need to meet specific race/gender targets, but balanced gender and African-Americans and Latino representation will be sought.
• Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.

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:

• 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
• 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)
• 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:

• 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.