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

Janssen-Cilag Farmaceutica Ltda.105 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

105

Conditions

HIV

Interventions

Antiretroviral TherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chlo - Hosp. Egas Moniz

Lisbon, Portugal

Outcomes

Primary Outcomes

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.

Time frame: Week 48

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline up to Week 48

Data from ClinicalTrials.gov

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