Clinical Trials Detalhe
A Study to Evaluate Virologic Response in Participants Newly Diagnosed With HIV-1
General Information
Gender
ALL
Age
N/A
Phase
N/A
Study Type
OBSERVATIONAL
Location
Chlo - Hosp. Egas Moniz (Lisboa, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT04147325Summary
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
Eligibility
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