Acute HIV InfectionPhase 4EMTreatEDNCT03711253
Empiric Treatment for Acute HIV in the ED
A Phase 4 study testing Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in people with Acute HIV Infection, run by University of Southern California at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute HIV Infection
- What is being tested?
- Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2019to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected acute HIV infection
- agree to start immediate ART and to storage of laboratory specimens
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
LA County-USC Medical Center Emergency Department
Los Angeles, California, 90033
Rand Schrader Health and Research Clinic
Los Angeles, California, 90033
About this study
Official title: Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
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
Read the 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.
- Conditions
- Acute HIV Infection
- Being tested
- Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
- Keywords
- acute hiv infection, emergency department, antiretroviral therapy
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mgDrug
Also called Biktarvy
antiretroviral therapy
| Study group | Role | What they receive |
|---|---|---|
| Biktarvy | Other | All participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study Receives: Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of immediate ART initiation
Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV
Measured: 1 day
Secondary outcomes (5)
Impact on linkage and engagement in care
Proportion with immediate ART for individuals with suspected acute HIV infection with linkage and 48 week engagement in care
Measured: 48 weeks
ART effects on cell associated HIV DNA
Changes in cell associated HIV DNA (assays TBD based on best practices at the time of study completion)
Measured: 48 weeks
ART effects leukocytes
Changes in proportion of activated lymphocytes activated monocytes
Measured: 48 weeks
ART effects inflammation
Changes C-reactive protein levels
Measured: 48 weeks
ART effects monocyte activation
Changes in soluble cd14 levels
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start14 Oct 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dube, University of Southern California
- Investigators
- Kathleen Jacobson, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711253
- Sponsor's protocol ID
- APP-18-01821
- Acronym
- EMTreatED
- Status last verified
- Apr 2023
- First submitted
- 26 Jul 2018
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
- ClinicalTrials.gov ID
- NCT03711253
- Acronym / sponsor ID
- EMTreatED / APP-18-01821
- Conditions
- Acute HIV Infection
- Keywords
- acute hiv infection, emergency department, antiretroviral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biktarvy | Other | Drug: Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mgAll participants get Biktarvy Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in this single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected acute HIV infection
- agree to start immediate ART and to storage of laboratory specimens
Key exclusion criteria (6 listed)
- Known chronic HIV infection
- severe renal or liver disease
- drug allergy/hypersensitivity
- prohibited medications
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mgAlso: Biktarvyantiretroviral therapy | Drug | Biktarvy |
Primary outcome
Acceptance of immediate ART initiation
Time frame: 1 day
Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV
5 secondary outcomes
Impact on linkage and engagement in care
Time frame: 48 weeks
ART effects on cell associated HIV DNA
Time frame: 48 weeks
ART effects leukocytes
Time frame: 48 weeks
ART effects inflammation
Time frame: 48 weeks
ART effects monocyte activation
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Acute HIV Infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Not yet recruitingPhase 1
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
HIV-1-infection
RecruitingPhase 2
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Acute HIV Infection
Recruiting
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
HIV-1-infection, HIV Seropositivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Jacobson, MD study chair
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg in people with Acute HIV Infection, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of immediate ART initiation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.