HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study will evaluate a three drug regimen in the form of two pills which will be taken
for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved
pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and
emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation,
raltegravir 400mg pill taken twice a day.

Inclusion Criteria:

- HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a
negative HIV-1 RNA assay

- Possible non-occupational exposure to HIV-1, recent enough to permit receiving the
first dose of study medication within 72 hours from the end of the exposure.

- Able to understand the study procedures and willing to sign informed consent

Exclusion Criteria:

- Any active psychiatric illness or active drug or alcohol abuse that, in the opinion
of the investigator, could prevent compliance with study procedures.

- Pregnancy.

- Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive
serum HBV DNA; or prior lamivudine therapy for hepatitis B.

- Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.

- Unwillingness to participate in study procedures, including Mental Health referral
and intervention.

- Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.

- Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which
cannot be used with raltegravir.