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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
antiretroviral therapy
LA County-USC Medical Center Emergency Department
Los Angeles, California, United States
Rand Schrader Health and Research Clinic
Los Angeles, California, United States
Acceptance of immediate ART initiation
Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV
Time frame: 1 day
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
Time frame: 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)
Time frame: 48 weeks
ART effects leukocytes
Changes in proportion of activated lymphocytes activated monocytes
Time frame: 48 weeks
ART effects inflammation
Changes C-reactive protein levels
Time frame: 48 weeks
ART effects monocyte activation
Changes in soluble cd14 levels
Time frame: 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.