HIV Non-Occupational Post-Exposure Prophylaxis

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenneth H. Mayer, MD
• Collaborator: Gilead Sciences
• Treatments: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

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.