Clinical Trials

MainTitle

Empiric Treatment for Acute HIV in the ED (EMTreatED)

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2019 by Michael Dube, University of Southern California

Sponsor
University of Southern California


Information provided by (Responsible Party)
Michael Dube, University of Southern California

ClinicalTrials.gov Identifier
NCT03711253

First received: July 26, 2018
Last updated: October 14, 2019
Last Verified: October 2019
History of Changes
Purpose

Purpose

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 Intervention Phase
Acute HIV Infection

Drug : Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
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

Further study details as provided by Michael Dube, University of Southern California:

Primary Outcome Measures

  • 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:
  • 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
  • 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)
  • ART effects leukocytes [ Time Frame: 48 weeks ]
    Changes in proportion of activated lymphocytes activated monocytes
  • ART effects inflammation [ Time Frame: 48 weeks ]
    Changes C-reactive protein levels
  • ART effects monocyte activation [ Time Frame: 48 weeks ]
    Changes in soluble cd14 levels

Estimated Enrollment: 40
Study Start Date: October 14, 2019
Estimated Study Completion Date: October 1, 2021
Estimated Primary Completion Date: April 1, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: Biktarvy

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03711253

Contacts

Contact:   Esther Lim, MPH (323) 865-1645 ext 6268909029 Esther.Lim@med.usc.edu
Contact:   Michael Dube, MD 323.409.8288 mdube@usc.edu

Locations

United States, California
LA County-USC Medical Center Emergency Department Recruiting
Los Angeles, California, United States, 90033
Contact: Michael Menchine, MD
Rand Schrader Health and Research Clinic Recruiting
Los Angeles, California, United States, 90033
Contact: Michael Dube, MD    323-409-8285    mdube@usc.edu
Contact: Luis Mendez, BA    323.409.8283    lmendez@usc.edu

Sponsors and Collaborators

University of Southern California

Investigators

Study Chair: Kathleen Jacobson, MD University of Southern California
More Information

More Information


Responsible Party: Michael Dube, Professor of Medicine, University of Southern California  
ClinicalTrials.gov Identifier: NCT03711253   History of Changes  
Other Study ID Numbers: APP-18-01821  
Study First Received: July 26, 2018  
Last Updated: October 14, 2019  
Individual Participant Data    
Plan to Share IPD: No  

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:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.