Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
- Conditions
- Acute HIV Infection
- Sponsor
- University of Southern California
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Acceptance of immediate ART initiation
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Michael Dube
Professor of Medicine
University of Southern California
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
Arms & Interventions
Biktarvy
All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study
Intervention: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
Outcomes
Primary Outcomes
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 Outcomes
- ART effects inflammation(48 weeks)
- ART effects monocyte activation(48 weeks)
- ART effects on cell associated HIV DNA(48 weeks)
- ART effects leukocytes(48 weeks)
- Impact on linkage and engagement in care(48 weeks)