Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Condition: HIV
Intervention: Truvada; Raltegravir
Intervention description: Tenofovir 200mg/emtricitabine 300mg once a day; Raltegravir 400mg twice a day
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; prevention; prophylaxis; Raltegravir; Truvada

Summary:

      This study will evaluate the safety and tolerability of the combination of truvada and
      raltegravir given for 28 days for the prevention of HIV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age

          -  HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and
             without any signs or symptoms of acute HIV infection

          -  Able to understand and provide consent

          -  High-Risk Exposure Characteristic (One or more of the below, unprotected or with
             failed condom use):

               -  Receptive Anal Intercourse

               -  Insertive Anal Intercourse

               -  Receptive Vaginal Intercourse

               -  Insertive Vaginal Intercourse

               -  Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source

          -  High-Risk Source (One or more of the below):

               -  Known HIV positive

               -  MSM

               -  MSM/W

               -  CSW

          -  Sexual perpetrator Partner of one of the above

          -  Exposure within 72 hours of presentation

          -  Not known to be HIV-1 positive

          -  No countermanding concomitant medications or allergies

        Exclusion Criteria:

          -  Patients <18 years of age

          -  Unable to understand and provide consent

          -  Non-occupational exposure to HIV-1 not recent enough to commence the first dose of
             study medication within 72 hours from the exposure

          -  Known to be HIV positive

          -  Any condition which in the opinion of the intake provider will seriously compromise
             the patient's ability to comply with the protocol, including adherence to nPEP
             medication

          -  Demonstrated HIV-1 positive on rapid testing

          -  Unwillingness to commit to barrier-method (male and/or female condom) use until HIV
             negative status is confirmed 6 months after exposure

          -  Unwillingness of breast-feeding women to transition to formula feeding

          -  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 or other therapy for hepatitis B

          -  Creatinine clearance less than 30 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