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

Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States

Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.

The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP from prior studies.

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 sexually transmitted infection (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 pre-exposure prophylaxis (PrEP);

• Willing to participate in behavioral intervention;

• Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; and

• Does not have a job or other obligations that would require long absences from the 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 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.