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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy | Other | All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg | Drug | antiretroviral therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Jacobson, MD | University of Southern California | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA County-USC Medical Center Emergency Department | Los Angeles | California | 90033 | United States | ||
| Rand Schrader Health and Research Clinic |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000620396 | bictegravir |
| D000068679 | Emtricitabine |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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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 |
| Los Angeles |
| California |
| 90033 |
| United States |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |