HIV Non-Occupational Post-Exposure Prophylaxis (QUAD)

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

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).

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)

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: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Community Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stribild; 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	Drug: Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg); Other Names: Stribild; QUAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Event Occurrences	The number of adverse events reported	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Self-Reported Missed Doses	self-reported missed doses	Day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
nPEP Failure (HIV Infection During Study Participation)	nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90	90 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• 2005 CDC Guidelines on Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: HIV; HIV prevention; Prophylaxis; PEP; Post Exposure Prophylaxis; nPEP; exposure to HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: QUAD (Other Identifier: HMH); IND: 116,967 (Other Identifier: FDA)