HIV Non-Occupational Post-Exposure Prophylaxis

Description

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

May 2013

Estimated Completion Date

August 2016

Interventions

  • Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)

Specialties

  • Obstetrics & Gynecology: Clinical Pharmacology,Preventive Medicine,STDs/Infections
  • Urology: Clinical Pharmacology,Infections/STDs
  • Infectious Disease: HIV/Immunodeficiency
  • Pharmacy: Drug Trials

MeSH Terms

  • Acquired Immunodeficiency Syndrome
  • HIV
  • Stribild

Study ID

Fenway Community Health -- QUAD

Status

Unknown

Trial ID

NCT01855867

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

120

Sponsor

Fenway Community Health

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Fenway Community Health - Boston, Massachusetts 2.4 miles None None None

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