Status:
COMPLETED
HIV Non-Occupational Post-Exposure Prophylaxis
Lead Sponsor:
Kenneth H. Mayer, MD
Collaborating Sponsors:
Gilead Sciences
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 da...
Detailed Description
Stribild is a combination of 1 integrase strand transfer inhibitor, 1 pharmacokinetic enhancer, and 2 nucleos(t)ide analog HIV-1 reverse transcriptase inhibitors, and was approved in August 2012, as a...
Eligibility Criteria
Inclusion
- \> 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)
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01855867
Start Date
May 1 2013
End Date
April 1 2016
Last Update
April 19 2022
Active Locations (1)
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1
Fenway Community Health
Boston, Massachusetts, United States, 02215