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HIV Non-Occupational Post-Exposure Prophylaxis (QUAD)

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Sponsored by
Kenneth H. Mayer, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring HIV, PEP, nPEP, Prophylaxis, Post Exposure Prophylaxis, exposure to HIV, HIV prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fenway Community Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stribild

Arm Description

Single dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV

Outcomes

Primary Outcome Measures

Number of Adverse Event Occurrences
The number of adverse events reported

Secondary Outcome Measures

Number of Participants With Self-Reported Missed Doses
self-reported missed doses

Full Information

First Posted
May 2, 2013
Last Updated
March 29, 2022
Sponsor
Kenneth H. Mayer, MD
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01855867
Brief Title
HIV Non-Occupational Post-Exposure Prophylaxis
Acronym
QUAD
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth H. Mayer, MD
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, PEP, nPEP, Prophylaxis, Post Exposure Prophylaxis, exposure to HIV, HIV prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stribild
Arm Type
Other
Arm Description
Single dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV
Intervention Type
Drug
Intervention Name(s)
Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Other Intervention Name(s)
Stribild, QUAD
Primary Outcome Measure Information:
Title
Number of Adverse Event Occurrences
Description
The number of adverse events reported
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of Participants With Self-Reported Missed Doses
Description
self-reported missed doses
Time Frame
Day 30
Other Pre-specified Outcome Measures:
Title
nPEP Failure (HIV Infection During Study Participation)
Description
nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth H. Mayer, MD
Organizational Affiliation
The Fenway Institute, Fenway Community Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fenway Community Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5402a1.htm
Description
2005 CDC Guidelines on Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States

Learn more about this trial

HIV Non-Occupational Post-Exposure Prophylaxis

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