Acute HIV Infection Clinical Trial
— EMTreatEDOfficial title:
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
Verified date | April 2023 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | LA County-USC Medical Center Emergency Department | Los Angeles | California |
United States | Rand Schrader Health and Research Clinic | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | ART effects leukocytes | Changes in proportion of activated lymphocytes activated monocytes | 48 weeks | |
Secondary | ART effects inflammation | Changes C-reactive protein levels | 48 weeks | |
Secondary | ART effects monocyte activation | Changes in soluble cd14 levels | 48 weeks |
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