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

NCT04147325 | Completed

• 2 other identifiers: CR108626TMC114HTX4016
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Percentage of Newly Diagnosed Participants with Human Immunodeficiency Virus (HIV)-1 Ribonucleic acid (RNA) < 50 Copies per Milliliter (c/mL) at Week 48 (Virologic Response)

  The percentage of newly diagnosed participants is defined as the percentage of newly HIV-1 infected participants that are considered virologic responders (that is have HIV-1 RNA viral load less than \[\<\] 50 c/mL) at Week 48 as per the Food And Drug Administration (FDA) snapshot algorithm.

  Week 48

Secondary Outcomes (12)

• Time to Antiretroviral Therapy (ART) Initiation since HIV-1 Diagnosis

  Up to 48 weeks

• Time to Virologic Suppression

  Up to 48 weeks

• Time to Virologic Response

  Up to 48 weeks

• Change from Baseline in HIV-1 RNA from Start of ART

  Baseline up to week 48

• Change from Baseline in Cluster Differentiation 4 (CD4) Cell Count

  Baseline up to Week 48

Study Arms (2)

Prospective Cohort

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.

Drug: Antiretroviral Therapy

Historical Cohort

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.

Drug: Antiretroviral Therapy

Interventions

Antiretroviral Therapy DRUG

ART will be administered chosen by the investigator according to country/ local standards/ guidelines/ available ARV for current treatment guidelines for rapid initiation.

Historical Cohort; Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants newly diagnosed with Human Immunodeficiency Virus (HIV)-1, who will be included in a Test and Treat model of care (Prospective Cohort) and naive HIV-infected participants who had their first care visit at the outpatient clinic of the center through 2017 (Retrospective Cohort) will be observed. Only data available as per clinical practice will be collected within this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Study Sites (1)

Chlo - Hosp. Egas Moniz

Lisbon, 1349-019, Portugal

Location

MeSH Terms

Interventions

Antiretroviral Therapy, Highly Active

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Janssen-Cilag Farmaceutica Ltda. Clinical Trial

  Janssen-Cilag Farmaceutica Ltda.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: December 17, 2019
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)