Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
CoDAR
Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
1 other identifier
observational
762
1 country
20
Brief Summary
This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2016
CompletedStudy Start
First participant enrolled
December 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2017
CompletedFebruary 5, 2020
December 1, 2016
5 months
December 19, 2016
February 3, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Virological effectiveness data: Percentage of patients with undetectable viral load
Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA \<50 copies / m.
24 weeks
Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
Change in the number of CD4 + T cells at 24 weeks
24 weeks
Virological effectiveness data: time to loss of virological efficacy.
Defined virological failure as two consecutive levels of HIV RNA \> 50 copies / mL or single HIV RNA ≥ 500 copies / mL
24 weeks
Secondary Outcomes (11)
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
48 weeks
Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
48 weeks
Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).
Basal and 24 weeks/48 weeks
Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.
basal and 24 weeks/48 weeks
Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT
basal and 24 weeks/48 weeks
- +6 more secondary outcomes
Study Arms (1)
DArunavir/cobicistat
Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks
Eligibility Criteria
HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
You may qualify if:
- Patients with HIV infection
- Inform consent document.
- To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.
You may not qualify if:
- Not having evaluable clinical data of the patient
- Patients not routinely followed in the center
- Patient less than 18 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- Janssen-Cilag, S.A.collaborator
Study Sites (20)
Hospital Costa del Sol
Málaga, 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
Málaga, Spain
Hospital de Son Llatzer
Palma de Mallorca, Spain
Hospital de Valme
Seville, Spain
Complejo Hospitalario de Toledo
Toledo, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital La Fe
Valencia, Spain
Complejo Hospitalaria Alvaron Cunqueiro
Vigo, Spain
Related Publications (2)
Perez Elias MJ, Alejos B, Gutierrez MM, Crespo M, De Los Santos Gil I, Ribera E, Galindo MJ, Lozano F, Payeras Cifre A, Boix V, Montero-Alonso M, Sanz J, De La Torre Lima J, Palacios R, De La Fuente Moral S, Martinez E; Codar Study Group. Dynamics of creatinine estimated glomerular filtration rate using one or more antiretrovirals that inhibit creatinine tubular secretion. J Antimicrob Chemother. 2021 Mar 12;76(4):1046-1050. doi: 10.1093/jac/dkaa547.
PMID: 33501995DERIVEDPerez Elias MJ, Alejos B, Vivancos MJ, Ribera E, Galindo MJ, Vilanova-Trillo L, Garcia-Fraile Fraile LJ, de La Fuente Moral S, Garcia De Lomas J, Lozano F, Mateo Garcia MG, Tasias Pitarch M, Diez Martinez M, Rojas J, Raya-Cruz M, Sepulveda MA, Troya J, Del Campo S, Martinez E; CODAR study group. Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316). J Antimicrob Chemother. 2019 Oct 1;74(10):3044-3048. doi: 10.1093/jac/dkz254.
PMID: 31236601DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2016
First Posted
February 3, 2017
Study Start
December 23, 2016
Primary Completion
May 9, 2017
Study Completion
May 9, 2017
Last Updated
February 5, 2020
Record last verified: 2016-12