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

Inclusion Criteria:

• Willing and able to provide written informed consent;
• Male gender at birth;
• Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of signed informed consent;
• Self reports evidence of high risk for acquiring HIV infection including at least one of the following:

• At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;

  • Anal intercourse with 3 or more male sex partners during the last 6 months;
  • Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;
  • Sex with a male partner and has had a STI during the last 6 months or at screening;
  • Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or
  • At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;
• Tests HIV antibody negative at time of screening;
• Willing to provide locator information to study staff;
• Willing to take PrEP;
• Willing to participate in behavioral intervention;
• Reports intention not to relocate out of AMTU study area during the course of the study; and
• Does not have a job or other obligations that would require long absences from AMTU study area (greater than 4 weeks at a time).

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 ATN 110 Protocol Team if they are having difficulty making the judgment.);
• History of bone fractures not explained by trauma;
• Weight > 350 pounds (159 kilograms);
• Acute or chronic hepatitis B infection as indicated by positive hepatitis B 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;
• Urine dipstick result of trace OR negative OR unconfirmed ≥ 1+ (i.e., urine dip ≥ 1+ which, on repeat dip does not confirm at > 1+) requires confirmatory testing with urinary protein-creatinine ratio (Up/cr) at time of screening. If Up/cr > 0.37 g/g, then the subject is not eligible;
• 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.