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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections

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

• Study Type: Observational
• Enrollment (Actual): 762

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Virological effectiveness data at 48 weeks	48 weeks
Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks	Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells	48 weeks
Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).	Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),	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.	Units: mg/dl or mmol/l	basal and 24 weeks/48 weeks
Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT	GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l	basal and 24 weeks/48 weeks
Tolerability data:Rate of patients discontinuing treatment for toxicity.	Toxicity to the treatment or virological failure	24 weeks/48 weeks
Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks	Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL	24 weeks/48 weeks
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.		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)		24 weeks / 48 weeks
Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen		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)		24 weeks / 48 weeks

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA
• Collaborators: Janssen-Cilag, S.A.

Publications and helpful links

General Publications

• 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.
• Perez 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. Erratum In: J Antimicrob Chemother. 2019 Oct 1;74(10):3124.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2016
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): May 9, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: GESIDA 9316