Empiric Treatment for Acute HIV in the ED (EMTreatED)

Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acute HIV Infection
• Intervention / Treatment: Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Esther Lim, MPH; Phone Number: 6268909029 (323) 865-1645; Email: Esther.Lim@med.usc.edu
• Study Contact Backup: Name: Michael Dube, MD; Phone Number: 323.409.8288; Email: mdube@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Rand Schrader Health and Research Clinic
    • Los Angeles, California, United States, 90033
      • LA County-USC Medical Center Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Biktarvy; 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 Names: Biktarvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of immediate ART initiation	Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on linkage and engagement in care	Proportion with immediate ART for individuals with suspected acute HIV infection with linkage and 48 week engagement in care	48 weeks
ART effects on cell associated HIV DNA	Changes in cell associated HIV DNA (assays TBD based on best practices at the time of study completion)	48 weeks
ART effects leukocytes	Changes in proportion of activated lymphocytes activated monocytes	48 weeks
ART effects inflammation	Changes C-reactive protein levels	48 weeks
ART effects monocyte activation	Changes in soluble cd14 levels	48 weeks

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Study Chair: Kathleen Jacobson, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: emergency department; antiretroviral therapy; acute hiv infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; 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; 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: APP-18-01821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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