Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03711253
Other study ID # APP-18-01821
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 14, 2019
Est. completion date June 1, 2023

Study information

Verified date April 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States LA County-USC Medical Center Emergency Department Los Angeles California
United States Rand Schrader Health and Research Clinic Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 48 weeks
Secondary 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) 48 weeks
Secondary ART effects leukocytes Changes in proportion of activated lymphocytes activated monocytes 48 weeks
Secondary ART effects inflammation Changes C-reactive protein levels 48 weeks
Secondary ART effects monocyte activation Changes in soluble cd14 levels 48 weeks
See also
  Status Clinical Trial Phase
Completed NCT02384395 - Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection N/A
Completed NCT00734344 - Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection N/A
Completed NCT01434706 - Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection N/A
Completed NCT01154673 - Intense Acute Infection Study Phase 2/Phase 3
Terminated NCT00855413 - HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine Phase 4
Completed NCT02467439 - Acute Partner and Social Contact Referral: iKnow N/A
Not yet recruiting NCT05719441 - A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission Phase 2
Completed NCT03579381 - Specimen Repository for HIV Immunopathogenesis
Completed NCT01369056 - HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence N/A
Completed NCT02170246 - Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection Phase 1
Completed NCT02750059 - Using Telmisartan With ART During Acute HIV Infection to Reduce the CNS Reservoirs of HIV and Lymph Node Fibrosis Phase 2
Completed NCT02470351 - Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS N/A
Completed NCT02475915 - Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection Phase 1/Phase 2
Completed NCT00924898 - Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805) Phase 4
Completed NCT02614950 - Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection N/A
Completed NCT01197027 - Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection Phase 3
Active, not recruiting NCT02231281 - Early cART and cART in Combination With Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in The Treatment of Acute HIV-1 Infected Adults Phase 3
Recruiting NCT05728996 - Netherlands Cohort Study on Acute HIV Infection
Recruiting NCT00796146 - Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
Recruiting NCT00796263 - Antiretroviral Therapy for Acute and Chronic HIV Infection Phase 3