Empiric Treatment for Acute HIV in the ED

NCT ID: NCT03711253

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2023-06-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Acute HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biktarvy

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

Group Type OTHER

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

Intervention Type DRUG

antiretroviral therapy

Interventions

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

antiretroviral therapy

Intervention Type DRUG

Other Intervention Names

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Biktarvy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Michael Dube

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen Jacobson, MD

Role: STUDY_CHAIR

University of Southern California

Locations

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LA County-USC Medical Center Emergency Department

Los Angeles, California, United States

Site Status

Rand Schrader Health and Research Clinic

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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APP-18-01821

Identifier Type: -

Identifier Source: org_study_id

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