Empiric Treatment for Acute HIV in the ED (EMTreatED)

University of Southern California

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute HIV Infection

Treatments: Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03711253

APP-18-01821

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Biktarvy

Other group

Description:

All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study

Treatment:

Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg