HIV Non-Occupational Post-Exposure Prophylaxis (QUAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Fenway Community Health
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT01855867
First received: May 2, 2013
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Human Immunodeficiency Virus
Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Awareness and attitudes around non-occupational post-prophylaxis [ Time Frame: Day 14 and Day 90 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Description of nPEP failure (HIV infection during study participation) [ Time Frame: Day 0 through 90 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Other Names:
  • Stribild
  • QUAD

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855867

Contacts
Contact: Charles Gregor, MPH 617-927-6124 cgregor@fenwayhealth.org
Contact: Marcy Gelman, RN, MPH 617-927-6440 mgelman@fenwayhealth.org

Locations
United States, Massachusetts
Fenway Community Health Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Kenneth Mayer, MPH         
Sponsors and Collaborators
Kenneth H. Mayer, MD
Gilead Sciences
Investigators
Principal Investigator: Kenneth H. Mayer, MD The Fenway Institute, Fenway Community Health
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth H. Mayer, MD, Medical Director, The Fenway Institute, Fenway Community Health
ClinicalTrials.gov Identifier: NCT01855867     History of Changes
Other Study ID Numbers: QUAD, IND: 116,967
Study First Received: May 2, 2013
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fenway Community Health:
HIV
PEP
nPEP
Prophylaxis
Post Exposure Prophylaxis
exposure to HIV
HIV prevention

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 18, 2014