Phase 4
N=100
HIV Non-Occupational Post-Exposure Prophylaxis
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT01855867 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Adverse Event Occurrences — 38; 28; 28; 14 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kenneth H. Mayer, MD
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Event Occurrences |
38; 28; 28; 14; 6; 2 | — |
| SECONDARY Number of Participants With Self-Reported Missed Doses |
29 | <0.05 sig |
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).
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:
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01855867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.