HIV Non-Occupational Post-Exposure Prophylaxis
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Intervention MeSH terms: Tenofovir; Emtricitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; PEP; nPEP; Prophylaxis; Post Exposure Prophylaxis; exposure to HIV; HIV prevention

Summary:

      The purpose of this study is to see if an anti-HIV medication known as Stribild
      (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when
      taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune
      Deficiency Virus (HIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  > Age of 18 at time of first visit.

          -  HIV uninfected on the basis of a negative HIV Rapid Test

          -  Willing and able to provide written informed consent.

          -  Willing and able to provide adequate locator information.

          -  Willing and able to return to all study visits.

          -  Willing to participate in all study procedures.

          -  Biologic women of childbearing potential: Willing to use contraception for as long as
             they are on study medication plus 7 days after.

          -  Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of
             study medication within 72 hours from the end of the exposure.

        possible exposure could include:

          1. Unprotected anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate
             from a partner who is HIV-1 infected or high risk for HIV infection and of unknown
             HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage
             or slippage); or

          2. Unprotected penile exposure to cervicovaginal secretions or anorectal secretions from
             a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1
             serostatus (may include protected sexual exposure with condom failure, breakage or
             slippage)

        Exclusion Criteria:

          -  An active psychiatric illness or active drug or alcohol abuse that, in the opinion of
             the investigator, could prevent compliance with study procedures.

          -  Pregnancy and/or Breastfeeding.

          -  Biologic women who are actively trying to become pregnant.

          -  Acute or Chronic Hepatitis B infection, by history

          -  Acute or Chronic Renal Disease, by history

          -  Creatinine Clearance at or below 70mL/min (Cockcroft-Gault equation, Actual Weight)

          -  Known intolerance or allergy to tenofovir DF, emtricitabine, elvitegravir or
             cobicistat

          -  Currently taking or plans to take prohibited medication while enrolled in the study.

               -  Prohibited Medications*

                    -  Propulsid (Cisapride)

                    -  UroXatral (Alfuzosin)

                    -  Dihydroergotamine

                    -  Ergotamine

                    -  Methylergonovine

                    -  St John's Wort (Hypericum perforatum)

                    -  Altocor, Altoprev, Mevacor (Lovastatin)

                    -  Zocor (Simvastatin)

                    -  Orap (Pimozide)

                    -  Rifadin, Rimactane (Rifampin)

                    -  Viagra (Sildenafil when dosed as REVATIO)

                    -  Halcion (Triazolam)

                    -  Versed (Midazolam) (when administered orally)

                    -  Antiretroviral medications used to treat or prevent HIV infection.