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Completed

NCT Number: NCT03042390

Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice

This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Costa del Sol, Málaga, Marbella, Spain

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About this study

The study will include 750 patients and will record data at 24 weeks. The study will also record data at 48 weeks for those patients whom these data are available

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with HIV infection
  • Inform consent document.
  • To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.

Exclusion criteria

  • Not having evaluable clinical data of the patient
  • Patients not routinely followed in the center
  • Patient less than 18 years of age.

Treatment and study plan

Primary outcomes

  1. Virological effectiveness data: Percentage of patients with undetectable viral load

    Time frame: 24 weeks

    Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m.

  2. Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks

    Time frame: 24 weeks

    Change in the number of CD4 + T cells at 24 weeks

  3. Virological effectiveness data: time to loss of virological efficacy.

    Time frame: 24 weeks

    Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL

Secondary outcomes

  1. Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks

    Time frame: 48 weeks

    Virological effectiveness data at 48 weeks

  2. Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks

    Time frame: 48 weeks

    Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells

  3. Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).

    Time frame: Basal and 24 weeks/48 weeks

    Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),

  4. Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.

    Time frame: basal and 24 weeks/48 weeks

    Units: mg/dl or mmol/l

  5. Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT

    Time frame: basal and 24 weeks/48 weeks

    GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l

  6. Tolerability data:Rate of patients discontinuing treatment for toxicity.

    Time frame: 24 weeks/48 weeks

    Toxicity to the treatment or virological failure

  7. Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks

    Time frame: 24 weeks/48 weeks

    Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL

  8. Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities.

    Time frame: 24 weeks/48 weeks

  9. Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others)

    Time frame: 24 weeks / 48 weeks

  10. Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen

    Time frame: 24 weeks / 48 weeks

  11. Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others)

    Time frame: 24 weeks / 48 weeks

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Janssen-Cilag, S.A.

Registry information

Official study title

Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice

Acronym: CoDAR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2017
Registry last updated
Feb 5, 2020

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

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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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