HIV
Conditions
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.
Interventions
DRUGAntiretroviral Therapy
ART will be administered chosen by the investigator according to country/ local standards/ guidelines/ available ARV for current treatment guidelines for rapid initiation.
Sponsors
Janssen-Cilag Farmaceutica Ltda.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Virologic Suppression | Up to 48 weeks | 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 to Virologic Response | Up to 48 weeks | Time to virologic response is defined as HIV-1 RNA viral load (VL) \< 200 copies/mL measured as per FDA snapshot algorithm. |
| Change from Baseline in HIV-1 RNA from Start of ART | Baseline up to week 48 | Change from baseline in HIV-1 RNA will be assessed through time (up to Week 48) from the date of start of ART. |
| Change from Baseline in Cluster Differentiation 4 (CD4) Cell Count | Baseline up to Week 48 | Change from baseline in CD4 cell count for immunologic changes after ART initiation will be determined. |
| Change from Baseline in Viral Load | Baseline up to Week 48 | Change from baseline in viral load for virologic changes after ART initiation will be determined. |
| Time to Antiretroviral Therapy (ART) Initiation since HIV-1 Diagnosis | Up to 48 weeks | Time to ART initiation is defined as time from HIV diagnosis (date of the first HIV positive test) to the start of ART. |
| Time from HIV Diagnosis to First Care Visit | Baseline (Day 1) | 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. |
| Time from First Care Visit to ART Initiation | Baseline (Day 1) | Time from first care visit to ART initiation in all newly diagnosed patients with HIV will be reported. |
| Percentage of Participants Developing PR, RT, and INI Resistance-Associated Mutation (RAMs) During Follow-up | Through 4, 6, 12, 24 and 48 weeks | Percentage of participants developing protease (PR), reverse transcriptase (RT), and integrase (INI) RAMs during follow-up will be reported. |
| Percentage of Participants who Loss-to-Follow According to Burkitt lymphoma (BL) CD4 cell Count | Up to 24 Months (end of study) | Percentage of participants who lost-to-follow up according to BL CD4 cell count, in all newly diagnosed participants with HIV will be reported. |
| Change from Baseline in ARV Regimen due to Resistance | Baseline up to Week 48 | Changes from baseline in ARV regimen due to resistance, will be evaluated in all newly diagnosed participants with HIV. |
| Percentage of Participants not Lost-to-Follow up | 12 months | The percentage of participants who maintained regular visits to the HIV center during a 12-month period after HIV diagnose period will be reported. |
Countries
Portugal
Outcome results
None listed