HIV Non-Occupational Post-Exposure Prophylaxis

NCT01855867 | Completed Phase 4 Results DMC

• 2 other identifiers: QUADIND: 116,967
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 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).

Conditions

Human Immunodeficiency Virus

Keywords

HIV; PEP; nPEP; Prophylaxis; Post Exposure Prophylaxis; exposure to HIV; HIV prevention

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Event Occurrences

  The number of adverse events reported

  90 days

Secondary Outcomes (1)

• Number of Participants With Self-Reported Missed Doses

  Day 30

Other Outcomes (1)

• nPEP Failure (HIV Infection During Study Participation)

  90 days

Study Arms (1)

Stribild

OTHER

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)

Interventions

Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) DRUG

Also known as: Stribild, QUAD

Stribild

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kenneth H. Mayer, MD: lead
• Gilead Sciences: collaborator

Study Sites (1)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

Related Links

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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine; Tenofovir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Thiazoles; Sulfur Compounds; Azoles; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Kenneth Mayer, Medical Research Director
• Organization: The Fenway Institute

kmayer@fenwayhealth.org

6179276374

Study Officials

• Kenneth H. Mayer, MD

  The Fenway Institute, Fenway Community Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, The Fenway Institute

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2016
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-03

Locations

US (1)