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Completed

NCT Number: NCT04147325

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chlo - Hosp. Egas Moniz

Lisbon, 1349-019, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antiretroviral therapy

Drug

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

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. Time to Antiretroviral Therapy (ART) Initiation since HIV-1 Diagnosis

    Time frame: 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.

  2. Time to Virologic Suppression

    Time frame: 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.

  3. Time to Virologic Response

    Time frame: 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.

  4. Change from Baseline in HIV-1 RNA from Start of ART

    Time frame: 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.

  5. Change from Baseline in Cluster Differentiation 4 (CD4) Cell Count

    Time frame: Baseline up to Week 48

    Change from baseline in CD4 cell count for immunologic changes after ART initiation will be determined.

  6. Change from Baseline in Viral Load

    Time frame: Baseline up to Week 48

    Change from baseline in viral load for virologic changes after ART initiation will be determined.

  7. Percentage of Participants not Lost-to-Follow up

    Time frame: 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.

  8. Time from HIV Diagnosis to First Care Visit

    Time frame: 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.

  9. Time from First Care Visit to ART Initiation

    Time frame: Baseline (Day 1)

    Time from first care visit to ART initiation in all newly diagnosed patients with HIV will be reported.

  10. Percentage of Participants Developing PR, RT, and INI Resistance-Associated Mutation (RAMs) During Follow-up

    Time frame: 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.

  11. Percentage of Participants who Loss-to-Follow According to Burkitt lymphoma (BL) CD4 cell Count

    Time frame: 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.

  12. Change from Baseline in ARV Regimen due to Resistance

    Time frame: Baseline up to Week 48

    Changes from baseline in ARV regimen due to resistance, will be evaluated in all newly diagnosed participants with HIV.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Farmaceutica Ltda.

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2019
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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