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

Virologic Response at 48 th Week, in Patients Newly Diagnosed With HIV-1, After the Implementation of a Test and Treat Model of Care, in a Single Portuguese Center.

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Antiretroviral Therapy

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1349-019
    • Chlo - Hosp. Egas Moniz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Antiretroviral Therapy (ART) Initiation since HIV-1 Diagnosis	Time to ART initiation is defined as time from HIV diagnosis (date of the first HIV positive test) to the start of ART.	Up to 48 weeks
Time to Virologic Suppression	Time to virologic suppression is defined as time from start of ART to the HIV RNA < 50 copies/mL measured as per FDA snapshot algorithm.	Up to 48 weeks
Time to Virologic Response	Time to virologic response is defined as HIV-1 RNA viral load (VL) < 200 copies/mL measured as per FDA snapshot algorithm.	Up to 48 weeks
Change from Baseline in HIV-1 RNA from Start of ART	Change from baseline in HIV-1 RNA will be assessed through time (up to Week 48) from the date of start of ART.	Baseline up to week 48
Change from Baseline in Cluster Differentiation 4 (CD4) Cell Count	Change from baseline in CD4 cell count for immunologic changes after ART initiation will be determined.	Baseline up to Week 48
Change from Baseline in Viral Load	Change from baseline in viral load for virologic changes after ART initiation will be determined.	Baseline up to Week 48
Percentage of Participants not Lost-to-Follow up	The percentage of participants who maintained regular visits to the HIV center during a 12-month period after HIV diagnose period will be reported.	12 months
Time from HIV Diagnosis to First Care Visit	Time from HIV diagnosis to first care visit will be performed by evaluating time between diagnosis of HIV and date of the first care visit.	Baseline (Day 1)
Time from First Care Visit to ART Initiation	Time from first care visit to ART initiation in all newly diagnosed patients with HIV will be reported.	Baseline (Day 1)
Percentage of Participants Developing PR, RT, and INI Resistance-Associated Mutation (RAMs) During Follow-up	Percentage of participants developing protease (PR), reverse transcriptase (RT), and integrase (INI) RAMs during follow-up will be reported.	Through 4, 6, 12, 24 and 48 weeks
Percentage of Participants who Loss-to-Follow According to Burkitt lymphoma (BL) CD4 cell Count	Percentage of participants who lost-to-follow up according to BL CD4 cell count, in all newly diagnosed participants with HIV will be reported.	Up to 24 Months (end of study)
Change from Baseline in ARV Regimen due to Resistance	Changes from baseline in ARV regimen due to resistance, will be evaluated in all newly diagnosed participants with HIV.	Baseline up to Week 48

Collaborators and Investigators

• Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Investigators: Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Janssen-Cilag Farmaceutica Ltda.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents
• Other Study ID Numbers: CR108626; TMC114HTX4016 (Other Identifier: Janssen-Cilag Farmaceutica Ltda.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No