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Empiric Treatment for Acute HIV in the ED (EMTreatED)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03711253
Recruitment Status : Not yet recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Information provided by (Responsible Party):
Michael Dube, University of Southern California

Brief Summary:
An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms

Condition or disease Intervention/treatment Phase
Acute HIV Infection Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg Phase 4

Detailed Description:
Individuals with suspected acute HIV infection willing to start immediate ART treatment will be given the ART regimen (bictegravir 50mg + tenofovir alafenamide 25 mg + emtricitabine 200 mg fixed dose combination) on the day of diagnosis. Those patients beginning immediate ART in the ED who are willing to have additional laboratory specimens drawn in the ED and become part of a cohort to receive ART and have ongoing biological specimens obtained and will be followed for 48 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study
Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
antiretroviral therapy
Other Name: Biktarvy

Primary Outcome Measures :
  1. Acceptance of immediate ART initiation [ Time Frame: 1 day ]
    Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV

Secondary Outcome Measures :
  1. Impact on linkage and engagement in care [ Time Frame: 48 weeks ]
    Proportion with immediate ART for individuals with suspected acute HIV infection with linkage and 48 week engagement in care

  2. ART effects on cell associated HIV DNA [ Time Frame: 48 weeks ]
    Changes in cell associated HIV DNA (assays TBD based on best practices at the time of study completion)

  3. ART effects leukocytes [ Time Frame: 48 weeks ]
    Changes in proportion of activated lymphocytes activated monocytes

  4. ART effects inflammation [ Time Frame: 48 weeks ]
    Changes C-reactive protein levels

  5. ART effects monocyte activation [ Time Frame: 48 weeks ]
    Changes in soluble cd14 levels

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Suspected acute HIV infection
  • agree to start immediate ART and to storage of laboratory specimens

Exclusion Criteria:

  • Known chronic HIV infection
  • severe renal or liver disease
  • drug allergy/hypersensitivity
  • prohibited medications
  • pregnancy
  • co-morbidity that the investigator feels would compromise safety, data interpretation, or achieving study objectives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03711253

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Contact: Esther Lim, MPH (323) 865-1645 ext 6268909029
Contact: Michael Dube, MD 323.409.8288

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United States, California
LA County-USC Medical Center Emergency Department Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Michael Menchine, MD         
Rand Schrader Health and Research Clinic
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
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Study Chair: Kathleen Jacobson, MD University of Southern California

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Responsible Party: Michael Dube, Professor of Medicine, University of Southern California Identifier: NCT03711253     History of Changes
Other Study ID Numbers: APP-18-01821
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michael Dube, University of Southern California:
acute hiv infection
emergency department
antiretroviral therapy

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