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HIV Non-Occupational Post-Exposure Prophylaxis (QUAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01855867
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

Tracking Information
First Submitted Date  ICMJE May 2, 2013
First Posted Date  ICMJE May 17, 2013
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE May 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
Safety and Tolerability - as measured by number of participants with adverse events, the severity of adverse events and frequency of adverse events [ Time Frame: Day 0, 14, 30 and 90 ]
Safety and tolerability will be measured by laboratory testing and clinical review of systems. Blood will be collected, via phlebotomy, at day 0, 30 and 90. Laboratory testing will include: CBC with differential, ALT, AST, total bilirubin, creatinine, BUN and hepatitis B at day 0. HIV testing will be done, by finger stick, at day 0, 30 and 90 - with confirmation testing if rapid testing indicates a reactive result or if acute seroconversion is suspected. HIV antigen testing will be conducted, via venipuncture, at day 90. Clinic staff will query participants on health status at day 0 and changes to their health on day 14, 30 and 90. If indicated, targeted physical exams will be offered. Adverse events, which are deemed related to the study intervention, will be followed until considered resolved or sequelae are considered permanent. Negative social impacts, due to study participation, will also be monitored from day 0 to day 90.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • Awareness and attitudes around non-occupational post-prophylaxis [ Time Frame: Day 14 and Day 90 ]
    To describe awareness and attitudes around nPEP among persons presenting for nPEP after a high-risk sexual contact, at day 14 and day 90. Perceptions will be collected by a computer based survey.
  • Awareness and attitudes around HIV pre-exposure prophylaxis [ Time Frame: Day 14 and Day 90 ]
    To describe awareness and attitudes around PrEP among persons presenting for NPEP after a high-risk sexual contact, at Day 14 and Day 90. Perceptions will be collected by a computer based survey.
  • Adherence compared to other nPEP regimens studied at Fenway Health or from literature review. [ Time Frame: Day 14 and 30 ]
    To compare adherence rates, based on self-reported missed doses and pill count with the investigational regimen, with historical adherence rates for NPEP regimens. Adherence will be measured by participant self report and pill count done at the clinic.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2013)
  • Description of nPEP failure (HIV infection during study participation) [ Time Frame: Day 0 through 90 ]
    Instances of NPEP failure (i.e., incident HIV infections during the study period) will be identified by HIV testing and stored plasma samples analysis collected at Day 0, 30 and 90. Additionally, HIV testing will be done if the participant presents or reports signs and/or symptoms of HIV seroconversion (i.e. fever, body aches, chills, rash). If available a description of the clinical status and disease state of the source individual will be developed. Additionally, characterization will be made of the infecting virus genotypically from both the infected subject and, if possible, from the source individual.
  • Safety, measured by number of participants that report adverse events and the associated severity, compared to other nPEP regimens studied at Fenway Health or from literature review. [ Time Frame: Day 0, 14, 30, 90 ]
    To compare the safety profile, developed from adverse events and severity, of Elivitegravir / Combicistat / Emtricitabine / Tenofovir Disoproxil Fumarate with other NPEP regimens and other Truvada containing regimens used in historical control.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE HIV Non-Occupational Post-Exposure Prophylaxis
Official Title  ICMJE A Phase IV Open-label Evaluation of Safety, Tolerability and Acceptability of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Disoproxil Fumarate Single-tablet Regimen for Non-occupational Prophylaxis Following Potential Exposure to HIV-1
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 day after a possible, sexual, exposure to the Human Immune Deficiency Virus (HIV).
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Other Names:
  • Stribild
  • QUAD
Study Arms  ICMJE Stribild
Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV
Intervention: Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2013)
120
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01855867
Other Study ID Numbers  ICMJE QUAD
IND: 116,967 ( Other Identifier: FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth H. Mayer, MD, Fenway Community Health
Study Sponsor  ICMJE Kenneth H. Mayer, MD
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Kenneth H. Mayer, MD The Fenway Institute, Fenway Community Health
PRS Account Fenway Community Health
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP