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Completed

NCT Number: NCT03577470

An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate

The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1)
  • Must sign a participation agreement/Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
  • Taking Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment:

i) Experienced participants [Group 1 and 2]: a) started their antiretroviral (ARV) treatment not before 1/1/2015, b) having at least 1 year of ARV treatment history at study enrollment, c) Group 1, having always been treated with Darunavir (DRV) since the start of ARV treatment as naïve, d) Group 2, not having been treated with DRV before starting of D/C/F/TAF, ii.) Naive (any Viral Load (VL) participants (Group 3)

Exclusion criteria

  • Participants unable to read, to write, to understand and sign the ICF
  • Currently enrolled in an interventional study
  • Currently enrolled in an observational study sponsored or supported by Janssen
  • Chemotherapy scheduled during study observation

Treatment and study plan

D/C/F/TAF Fixed-Dose Combination (FDC)

Drug

Participants in treatment with D/C/F/TAF FDC, coming from different treatment histories will be observed in this study. No interventions will be administered as a part of this study.

Other names: Symtuza

Primary outcomes

  1. Percentage of Participants with Virological Response at Week 48

    Time frame: At Week 48

    Percentage of participants with virologic response defined as plasma Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load (VL) less than (<) 50 copies per milliliter (cp/mL) measured according to Food and Drug Administration (FDA) snapshot algorithm will be reported.

Secondary outcomes

  1. Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)

    Time frame: At Baseline (Visit 1)

    Participants previous antiretroviral (ARV) treatment history will be determined using the web-based electronic case report form (eCRF) which will be prepared based on the study flow chart.

  2. Time to Virosuppression

    Time frame: At Baseline (Visit 1)

    For participants entering with VL greater than (>) 50cp/mL, the time to virosuppression will be recorded.

  3. Number of Participants with Detectability Below Level of Quantification <50 copies/mL

    Time frame: At Baseline (Visit 1)

    Number of participants with detectability below level of quantification <50 copies/mL will be reported.

  4. Cluster Differentiation 4 (CD4) Cells Nadir Count

    Time frame: At Baseline (Visit 1)

    CD4 cells nadir count will be reported.

  5. CD4 Cell Count

    Time frame: At Baseline (Visit 1)

    CD4 cells count will be reported.

  6. Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio

    Time frame: At Baseline (Visit 1)

    CD4/CD8 ratio will be reported.

  7. Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age

    Time frame: Up to Week 48

    The percentage of participants having virological response defined as plasma HIV-RNA VL< 50 cp/mL measured by the FDA snapshot algorithm, stratified by age [<50, greater than (>) 50 and < 65, > 65 years according to participants' number] will be reported.

  8. Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Gender at Birth

    Time frame: Up to Week 48

    The percentage of participants having virological response defined as plasma HIV-RNA VL< 50 cp/mL measured by the FDA snapshot algorithm, stratified by gender at birth will be reported.

  9. Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Original Group

    Time frame: Up to Week 48

    The percentage of participants having virological response defined as plasma HIV-RNA VL< 50 cp/mL measured by the FDA snapshot algorithm, stratified by original group will be reported.

  10. Percentage of Participants Withdrawing From the Study for any Reason

    Time frame: Up to Week 48

    The percentage of participants withdrawing from the study for any reason will be reported.

  11. Percentage of Participants who are Virologic Responders (VL<50 cp/mL) Measured by the Time to Loss of Virological Response (TLOVR) Algorithm

    Time frame: Up to Week 48

    The percentage of participants having virological response defined as VL< 50 cp/mL, measured by the TLOVR algorithm dataset will be reported. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.

  12. Percentage of Participants with Virological Failure in Virosuppressed Participants

    Time frame: Up to Week 48

    Percentage of participants with virological failure (two consecutive measures of VL greater than or equal to (>=) 50cp/mL) in virosuppressed participants with virological rebound will be calculated and reported.

  13. Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48

    Time frame: Baseline and Week 48

    The HIV-TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment by specific items that includes current treatment, control, side effects, demands, convenience, flexibility, understanding, lifestyle, recommend to others, continue. The HIV-TSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. HIV-TSQs will be recorded onto paper forms and will be considered as source data.

  14. Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48

    Time frame: Baseline and Week 48

    Narrative plots will be recorded onto paper forms and will be considered as source data to describe the participants experience during treatment.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag S.p.A.

Industry

Registry information

Official study title

Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE

Acronym: DIAMANTE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2018
Registry last updated
Oct 15, 2024

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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