Empiric Treatment for Acute HIV in the ED

Study Overview
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Brief Summary
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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
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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.

Official Title
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Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department

Conditions
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Acute HIV Infection

Intervention / Treatment
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* Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biktarvy<br>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<br>* antiretroviral therapy<br>* Other names: Biktarvy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute hiv infection, emergency department, antiretroviral therapy