Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation

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• Inability to give informed consent
• Pregnancy or planning to become pregnant within 3 months of study completion
• Currently 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 condom-less intercourse with HIV-infected 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 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.
• Uncontrolled or symptomatic bone disease or history of non-traumatic bone fractures
• Active psychiatric illness or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements
• Creatinine clearance \< 60 ml/min, or history of serious renal disease
• 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.
• Any laboratory value or uncontrolled medical conditions that, in the opinion of investigators, would interfere with the study conditions or increase risk to the participant
• \> Grade I abnormalities in screening laboratory tests (Complete Blood Count, Comprehensive Metabolic Panel, Lipase, Phosphorus) per Division of AIDS (DAIDS) Grading Table
• Contraindicated concomitant medications based upon product information or that, in the opinion of the investigators, would interact with the study medications or increase risk to participant such as: 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.
• +1 more criteria

Contact the study team to confirm eligibility.

Primary Completion