Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01855867
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01855867
Study Brief:
Protocol Section:
NCT01855867