A Study to Evaluate Virologic Response in Participants Newly Diagnosed With HIV-1

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: HIV

Treatments: Drug: Antiretroviral Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT04147325

CR108626

TMC114HTX4016 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the proportion of newly diagnosed participants with Human Immunodeficiency Virus (HIV)-1 (naive participants) with virologic response at Week 48-defined as HIV-1 Ribonucleic acid (RNA) less than (<) 50 copies/milliliter (mL) (Food And Drug Administration snapshot) - after the implementation of the Test & Treat model of care and in a historical cohort.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prospective cohort: Newly diagnosed with Human Immunodeficiency Virus (HIV)-1 evidenced by any of the following: or HIV Rapid Antibody positive; HIV Immunoassay positive; positive HIV (p24) antigen; or detectable HIV-1 Ribonucleic acid (RNA) Viral Load and non-reactive antibody/antigen assays. HIV-1 RNA Viral Load must be confirmed within one week of initial HIV-1 RNA Viral Load test
• Prospective cohort: Antiretroviral (ARV) treatment-naïve who will initiate treatment. Retrospective cohort: Dates of HIV-1 diagnosis and ARV treatment initiation available in clinical records
• Prospective and Retrospective cohorts: Must sign [and/or their legally-acceptable representative where applicable must sign,] a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion criteria

• Known Acquired Immune Deficiency Syndrome (AIDS)-defining condition
• Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Antiretroviral Therapy (ART)
• Known history of chronic renal insufficiency, defined as having an eGFR less than (<) 50 milliliter/minute (ml/min) according to the Cockcroft-Gault formula
• Known active severe infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to screening
• Known history of cirrhosis as diagnosed based on local practices

Trial design

105 participants in 2 patient groups

Prospective Cohort

Description:

Participants newly diagnosed with Human Immunodeficiency Virus (HIV)-1, will receive Antiretroviral Therapy (ART) in accordance with clinical practice and will be included in a Test and Treat model of care at the outpatient clinic of the center.

Treatment:

Drug: Antiretroviral Therapy

Historical Cohort

Description:

Naive HIV-1 infected participants who had their first care visit at the outpatient clinic of the center through 2017 will be included in this cohort.

Treatment:

Drug: Antiretroviral Therapy