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Empiric Treatment for Acute HIV in the ED (EMTreatED)

Primary Purpose

Acute HIV Infection

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute HIV Infection focused on measuring acute hiv infection, emergency department, antiretroviral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LA County-USC Medical Center Emergency Department
  • Rand Schrader Health and Research Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biktarvy

Arm Description

All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study

Outcomes

Primary Outcome Measures

Acceptance of immediate ART initiation
Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV

Secondary Outcome Measures

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
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)
ART effects leukocytes
Changes in proportion of activated lymphocytes activated monocytes
ART effects inflammation
Changes C-reactive protein levels
ART effects monocyte activation
Changes in soluble cd14 levels

Full Information

First Posted
July 26, 2018
Last Updated
April 24, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03711253
Brief Title
Empiric Treatment for Acute HIV in the ED
Acronym
EMTreatED
Official Title
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute HIV Infection
Keywords
acute hiv infection, emergency department, antiretroviral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biktarvy
Arm Type
Other
Arm Description
All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study
Intervention Type
Drug
Intervention Name(s)
Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
Other Intervention Name(s)
Biktarvy
Intervention Description
antiretroviral therapy
Primary Outcome Measure Information:
Title
Acceptance of immediate ART initiation
Description
Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Impact on linkage and engagement in care
Description
Proportion with immediate ART for individuals with suspected acute HIV infection with linkage and 48 week engagement in care
Time Frame
48 weeks
Title
ART effects on cell associated HIV DNA
Description
Changes in cell associated HIV DNA (assays TBD based on best practices at the time of study completion)
Time Frame
48 weeks
Title
ART effects leukocytes
Description
Changes in proportion of activated lymphocytes activated monocytes
Time Frame
48 weeks
Title
ART effects inflammation
Description
Changes C-reactive protein levels
Time Frame
48 weeks
Title
ART effects monocyte activation
Description
Changes in soluble cd14 levels
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Jacobson, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
LA County-USC Medical Center Emergency Department
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Rand Schrader Health and Research Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Empiric Treatment for Acute HIV in the ED

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