HIV Non-Occupational Post-Exposure Prophylaxis

Completed · Phase 4

Conditions studied: Human Immunodeficiency Virus

In brief

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).

Key facts

Study ID

NCT01855867

Run by

Kenneth H. Mayer, MD

People needed

100

Starts

2013-05-01

Expected to finish

2016-04-01

Last updated by the study team

2022-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• > 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:
• 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
• 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)

You may not qualify if…

• 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.

Where it is running

• Fenway Community Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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