HIV Non-Occupational Post-Exposure Prophylaxis
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).
Study Start Date
Estimated Completion Date
- Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
- Obstetrics & Gynecology: Clinical Pharmacology,Preventive Medicine,STDs/Infections
- Urology: Clinical Pharmacology,Infections/STDs
- Infectious Disease: HIV/Immunodeficiency
- Pharmacy: Drug Trials
- Acquired Immunodeficiency Syndrome
Fenway Community Health -- QUAD
Fenway Community Health
- > 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)
- 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)
- 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.
18 Years and older
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Fenway Community Health - Boston, Massachusetts||2.4 miles||None||None||None|