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HIVNCT04147325

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

An observational study of HIV, run by Janssen-Cilag Farmaceutica Ltda. at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Antiretroviral Therapy
How many people
105 participants
Where
1 sitePortugal
Study dates
17 Dec 2019to 12 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Chlo - Hosp. Egas Moniz

    Lisbon, 1349-019

Other trials in Portugal

About this study

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.

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
Being tested
Antiretroviral Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiretroviral TherapyDrug

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

Study groups in NCT04147325
Study groupRoleWhat they receive
Prospective CohortParticipants newly diagnosed with Human Immunodeficiency Virus (HIV)-1, will receive Antiretroviral Therapy (ART) in accordance with clinical practice and will be included in a Test and Treat model of care at the outpatient clinic of the center.
Receives: Drug: Antiretroviral Therapy
Historical CohortNaive HIV-1 infected participants who had their first care visit at the outpatient clinic of the center through 2017 will be included in this cohort.
Receives: Drug: Antiretroviral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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.

    Measured: Week 48

Secondary outcomes (12)

  1. 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.

    Measured: Up to 48 weeks

  2. 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.

    Measured: Up to 48 weeks

  3. 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.

    Measured: Up to 48 weeks

  4. 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.

    Measured: Baseline up to week 48

  5. 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.

    Measured: Baseline up to Week 48

  6. Change from Baseline in Viral Load

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

    Measured: Baseline up to Week 48

  7. 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.

    Measured: 12 months

  8. 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.

    Measured: Baseline (Day 1)

  9. 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.

    Measured: Baseline (Day 1)

  10. 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.

    Measured: Through 4, 6, 12, 24 and 48 weeks

  11. 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.

    Measured: Up to 24 Months (end of study)

  12. 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.

    Measured: Baseline up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start17 Dec 2019
  3. Primary completion12 Dec 2022
  4. Study completion12 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147325
Sponsor's protocol ID
CR108626
Other IDs
TMC114HTX4016
Status last verified
Dec 2023
First submitted
30 Oct 2019
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by Janssen-Cilag Farmaceutica Ltda. at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04147325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.

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