Acute HIV Infection
Conditions
Keywords
acute hiv infection, emergency department, antiretroviral therapy
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.
Interventions
DRUGBictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
antiretroviral therapy
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of immediate ART initiation | 1 day | Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ART effects inflammation | 48 weeks | Changes C-reactive protein levels |
| Impact on linkage and engagement in care | 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 | 48 weeks | Changes in cell associated HIV DNA (assays TBD based on best practices at the time of study completion) |
| ART effects leukocytes | 48 weeks | Changes in proportion of activated lymphocytes activated monocytes |
| ART effects monocyte activation | 48 weeks | Changes in soluble cd14 levels |
Countries
United States
Outcome results
None listed