Clinical trial
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
Name
APP-18-01821
Description
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
Trial arms
Trial start
2019-10-14
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
antiretroviral therapy
Arms:
Biktarvy
Other names:
Biktarvy
Size
40
Primary endpoint
Acceptance of immediate ART initiation
1 day
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-04-26
1 organization
1 product
1 indication
Organization
University of Southern CaliforniaIndication
Acute HIV Infection