NCT03711253

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

July 26, 2018

Last Update Submit

April 24, 2023

Conditions

Acute HIV Infection

Keywords

acute hiv infectionemergency departmentantiretroviral therapy

Outcome Measures

Primary Outcomes (1)

  • Acceptance of immediate ART initiation

    Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV

    1 day

Secondary Outcomes (5)

  • Impact on linkage and engagement in care

    48 weeks

  • ART effects on cell associated HIV DNA

    48 weeks

  • ART effects leukocytes

    48 weeks

  • ART effects inflammation

    48 weeks

  • ART effects monocyte activation

    48 weeks

Study Arms (1)

Biktarvy

OTHER

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

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

Interventions

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

antiretroviral therapy

Also known as: Biktarvy
Biktarvy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LA County-USC Medical Center Emergency Department

Los Angeles, California, 90033, United States

Location

Rand Schrader Health and Research Clinic

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Emergencies

Interventions

bictegravirEmtricitabinebictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Kathleen Jacobson, MD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 26, 2018

First Posted

October 18, 2018

Study Start

October 14, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)