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

HIV Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147325
• Other study ID #: CR108626
• Secondary ID: TMC114HTX4016
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2023
• Source: Janssen-Cilag Farmaceutica Ltda.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Portugal	Chlo - Hosp. Egas Moniz	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Farmaceutica Ltda.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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