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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Fundacion SEIMC-GESIDA

Collaborator
Janssen-Cilag, S.A.

Information provided by (Responsible Party)
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier
NCT03042390

First received: December 19, 2016
Last updated: July 7, 2017
Last Verified: December 2016
History of Changes
Purpose

Purpose

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

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice

Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures

  • 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.
  • 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
  • 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 Outcome Measures:
  • 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
  • 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
  • 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),
  • 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
  • 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
  • Tolerability data:Rate of patients discontinuing treatment for toxicity. [ Time Frame: 24 weeks/48 weeks ]
    Toxicity to the treatment or virological failure
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 762
Study Start Date: December 23, 2016
Study Completion Date: May 9, 2017
Primary Completion Date: May 9, 2017 (Final data collection date for primary outcome measure)

Arms
DArunavir/cobicistat
Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks

Detailed Description:

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03042390

Locations

Spain
Hospital Costa del Sol
Malaga, Marbella, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital del Vall d'Hebron
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital de Guadalajara
Guadalajara, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital La Princesa
Madrid, Spain
Hospital Príncipe de Asturias
Madrid, Spain
Hospital Puerta de Hierro
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Virgen de la Victoria
Malaga, Spain
Hospital de Son Llatzer
Palma de Mallorca, Spain
Hospital de Valme
Sevilla, Spain
Complejo Hospitalario de Toledo
Toledo, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital La Fe
Valencia, Spain
Complejo Hospitalaria Alvaron Cunqueiro
Vigo, Spain

Sponsors and Collaborators

Fundacion SEIMC-GESIDA
Janssen-Cilag, S.A.
More Information

More Information


Responsible Party: Fundacion SEIMC-GESIDA  
ClinicalTrials.gov Identifier: NCT03042390   History of Changes  
Other Study ID Numbers: GESIDA 9316  
Study First Received: December 19, 2016  
Last Updated: July 7, 2017  

Additional relevant MeSH terms:
HIV Infections
Darunavir
Cobicistat

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.