Empiric Treatment for Acute HIV in the ED

  • STATUS
    Recruiting
  • End date
    Oct 1, 2021
  • participants needed
    40
  • sponsor
    University of Southern California
Updated on 23 January 2021

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

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.

Details
Condition Acute HIV Infection
Treatment Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
Clinical Study IdentifierNCT03711253
SponsorUniversity of Southern California
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Acute HIV Infection??
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
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