Clinical trial NCT04147325: A Study to Evaluate Virologic Response in Participants Newly Diagnosed With HIV-1
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Week 48
Secondary outcomes:
measure: Time to Antiretroviral Therapy (ART) Initiation since HIV-1 Diagnosis
timeFrame: Up to 48 weeks
measure: Time to Virologic Suppression
timeFrame: Up to 48 weeks
measure: Time to Virologic Response
timeFrame: Up to 48 weeks
measure: Change from Baseline in HIV-1 RNA from Start of ART
timeFrame: Baseline up to week 48
measure: Change from Baseline in Cluster Differentiation 4 (CD4) Cell Count
timeFrame: Baseline up to Week 48
measure: Change from Baseline in Viral Load
timeFrame: Baseline up to Week 48
measure: Percentage of Participants not Lost-to-Follow up
timeFrame: 12 months
measure: Time from HIV Diagnosis to First Care Visit
timeFrame: Baseline (Day 1)
measure: Time from First Care Visit to ART Initiation
timeFrame: Baseline (Day 1)
measure: Percentage of Participants Developing PR, RT, and INI Resistance-Associated Mutation (RAMs) During Follow-up
timeFrame: Through 4, 6, 12, 24 and 48 weeks
measure: Percentage of Participants who Loss-to-Follow According to Burkitt lymphoma (BL) CD4 cell Count
timeFrame: Up to 24 Months (end of study)
measure: Change from Baseline in ARV Regimen due to Resistance
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Chlo - Hosp. Egas Moniz
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References: