An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis

Exclusion Criteria

• •Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent;
• •Intoxicated or under the influence of alcohol or other drugs at the time of consent;
• •Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 Protocol Team if they are having difficulty making the judgment.);
• •History of bone fractures not explained by trauma;
• •Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;
• •Confirmed renal dysfunction (Creatinine Clearance (CrCl) \< 75 ml/min, or serum creatinine ≥ upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;
• •Confirmed ≥ Grade 2 hypophosphatemia at time of screening;
• •Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;
• •Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;
• •Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio(UP/C);
• •UP/C \> 0.37 g/g at time of screening, regardless of urine dipstick protein result;
• •Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (\<120 mg/dL) at time of screening;
• •A confirmed Grade ≥ 3 toxicity on any screening evaluations;
• •Known allergy/sensitivity to the study agent or its components;
• •Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies;
• •Use of disallowed medications ; or
• •Inability to understand spoken English.