Recruitment

Recruitment Status
Completed
Estimated Enrollment
120

Inclusion Criterias

Willing and able to return to all study visits.
Biologic women of childbearing potential: Willing to use contraception for as long as they are on study medication plus 7 days after.
HIV uninfected on the basis of a negative HIV Rapid Test
...
Willing and able to return to all study visits.
Biologic women of childbearing potential: Willing to use contraception for as long as they are on study medication plus 7 days after.
HIV uninfected on the basis of a negative HIV Rapid Test
Willing and able to provide adequate locator information.
Willing and able to provide written informed consent.
> Age of 18 at time of first visit.
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.
Willing to participate in all study procedures.

Exclusion Criterias

Creatinine Clearance at or below 70mL/min (Cockcroft-Gault equation, Actual Weight)
An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
Viagra (Sildenafil when dosed as REVATIO)
...
Creatinine Clearance at or below 70mL/min (Cockcroft-Gault equation, Actual Weight)
An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
Viagra (Sildenafil when dosed as REVATIO)
Propulsid (Cisapride)
Altocor, Altoprev, Mevacor (Lovastatin)
Halcion (Triazolam)
St John's Wort (Hypericum perforatum)
Zocor (Simvastatin)
Orap (Pimozide)
Antiretroviral medications used to treat or prevent HIV infection.
Known intolerance or allergy to tenofovir DF, emtricitabine, elvitegravir or cobicistat
Acute or Chronic Renal Disease, by history
Rifadin, Rimactane (Rifampin)
UroXatral (Alfuzosin)
Biologic women who are actively trying to become pregnant.
Pregnancy and/or Breastfeeding.
Versed (Midazolam) (when administered orally)
Acute or Chronic Hepatitis B infection, by history
Methylergonovine
Dihydroergotamine
Ergotamine

Summary

Conditions
Human Immunodeficiency Virus
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 complete treatment regimen for HIV-1 infection in adults who are antiretroviral treatment-naïve. We...

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 complete treatment regimen for HIV-1 infection in adults who are antiretroviral treatment-naïve. We are proposing to evaluate the safety, tolerability and acceptability of Stribild given to participants over age 18 after a possible sexual exposure to HIV-1. Enrolled participants will have experienced a moderate to high risk exposure, as outlined in the study protocol, within the last 72 hours - per 2005 Center for Disease Control and Prevention guidelines. Participants will take one Stribild tablet, by mouth, once a day for 28 days. Study staff will assess for changes in blood chemistries and clinical signs and symptoms from baseline health. Study participation is 90 days and will include HIV testing, STI screening, HIV/STI risk reduction counseling, clinical assessments, blood draws and surveys designed to gather knowledge and perception of HIV post-exposure prophylaxis (PEP) and HIV pre-exposure prophylaxis (PrEP). Conditional referrals to continued HIV/STI risk reduction counseling and testing will be made if risk remains high at study termination. In addition, participants will be connected to a medical provider if risk demonstrates a potential need for HIV pre-exposure prophylaxis.

Inclusion Criterias

Willing and able to return to all study visits.
Biologic women of childbearing potential: Willing to use contraception for as long as they are on study medication plus 7 days after.
HIV uninfected on the basis of a negative HIV Rapid Test
...
Willing and able to return to all study visits.
Biologic women of childbearing potential: Willing to use contraception for as long as they are on study medication plus 7 days after.
HIV uninfected on the basis of a negative HIV Rapid Test
Willing and able to provide adequate locator information.
Willing and able to provide written informed consent.
> Age of 18 at time of first visit.
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.
Willing to participate in all study procedures.

Exclusion Criterias

Creatinine Clearance at or below 70mL/min (Cockcroft-Gault equation, Actual Weight)
An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
Viagra (Sildenafil when dosed as REVATIO)
...
Creatinine Clearance at or below 70mL/min (Cockcroft-Gault equation, Actual Weight)
An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
Viagra (Sildenafil when dosed as REVATIO)
Propulsid (Cisapride)
Altocor, Altoprev, Mevacor (Lovastatin)
Halcion (Triazolam)
St John's Wort (Hypericum perforatum)
Zocor (Simvastatin)
Orap (Pimozide)
Antiretroviral medications used to treat or prevent HIV infection.
Known intolerance or allergy to tenofovir DF, emtricitabine, elvitegravir or cobicistat
Acute or Chronic Renal Disease, by history
Rifadin, Rimactane (Rifampin)
UroXatral (Alfuzosin)
Biologic women who are actively trying to become pregnant.
Pregnancy and/or Breastfeeding.
Versed (Midazolam) (when administered orally)
Acute or Chronic Hepatitis B infection, by history
Methylergonovine
Dihydroergotamine
Ergotamine

Locations

Boston, Massachusetts, 02215
Boston, Massachusetts, 02215

Tracking Information

NCT #
NCT01855867
Collaborators
Gilead Sciences
Investigators
  • Principal Investigator: Kenneth H. Mayer, MD The Fenway Institute, Fenway Community Health
  • Kenneth H. Mayer, MD The Fenway Institute, Fenway Community Health