Empiric Treatment for Acute HIV in the ED

Phase 4

Active, not recruiting

• Conditions: Acute HIV Infection
• Interventions: Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg

• Registration Number: NCT03711253
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Study Start: 2019-10-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Suspected acute HIV infection
• agree to start immediate ART and to storage of laboratory specimens

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ART effects monocyte activation	48 weeks	Changes in soluble cd14 levels
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

Trial Locations

Locations (2)

Rand Schrader Health and Research Clinic; 🇺🇸 Los Angeles, California, United States

LA County-USC Medical Center Emergency Department; 🇺🇸 Los Angeles, California, United States