Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice (CoDAR)
3. februar 2020 opdateret af: Fundacion SEIMC-GESIDA
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
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
762
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Barcelona, Spanien
- Hospital Del Mar
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Barcelona, Spanien
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spanien
- Hospital Clinic I Provincial
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Barcelona, Spanien
- Hospital Germans Trías i Pujol
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Barcelona, Spanien
- Hospital del Vall d'Hebron
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Guadalajara, Spanien
- Hospital de Guadalajara
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Madrid, Spanien
- Hospital Ramon y Cajal
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Madrid, Spanien
- Hospital La Paz
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Madrid, Spanien
- Hospital La Princesa
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Madrid, Spanien
- Hospital Infanta Leonor
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Madrid, Spanien
- Hospital Puerta de Hierro
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Madrid, Spanien
- Hospital Principe de Asturias
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Malaga, Spanien
- Hospital Virgen de la Victoria
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Palma de Mallorca, Spanien
- Hospital de Son Llàtzer
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Sevilla, Spanien
- Hospital De Valme
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Toledo, Spanien
- Complejo Hospitalario de Toledo
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Valencia, Spanien
- Hospital Clínico de Valencia
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Valencia, Spanien
- Hospital La Fe
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Vigo, Spanien
- Complejo Hospitalaria Alvaron Cunqueiro
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Marbella
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Malaga, Marbella, Spanien
- Hospital Costa del Sol
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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DArunavir/cobicistat
Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Virological effectiveness data: Percentage of patients with undetectable viral load
Tidsramme: 24 weeks
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Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m.
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24 weeks
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Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
Tidsramme: 24 weeks
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Change in the number of CD4 + T cells at 24 weeks
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24 weeks
|
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Virological effectiveness data: time to loss of virological efficacy.
Tidsramme: 24 weeks
|
Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 48 weeks
|
Virological effectiveness data at 48 weeks
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48 weeks
|
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Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
Tidsramme: 48 weeks
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Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells
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48 weeks
|
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Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).
Tidsramme: Basal and 24 weeks/48 weeks
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Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),
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Basal and 24 weeks/48 weeks
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Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.
Tidsramme: basal and 24 weeks/48 weeks
|
Units: mg/dl or mmol/l
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basal and 24 weeks/48 weeks
|
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Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT
Tidsramme: basal and 24 weeks/48 weeks
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GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml.
BrT in units: mg/dl or micromol/l
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basal and 24 weeks/48 weeks
|
|
Tolerability data:Rate of patients discontinuing treatment for toxicity.
Tidsramme: 24 weeks/48 weeks
|
Toxicity to the treatment or virological failure
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24 weeks/48 weeks
|
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Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks
Tidsramme: 24 weeks/48 weeks
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Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
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24 weeks/48 weeks
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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.
Tidsramme: 24 weeks/48 weeks
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24 weeks/48 weeks
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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)
Tidsramme: 24 weeks / 48 weeks
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24 weeks / 48 weeks
|
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Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen
Tidsramme: 24 weeks / 48 weeks
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24 weeks / 48 weeks
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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)
Tidsramme: 24 weeks / 48 weeks
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24 weeks / 48 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. december 2016
Primær færdiggørelse (Faktiske)
9. maj 2017
Studieafslutning (Faktiske)
9. maj 2017
Datoer for studieregistrering
Først indsendt
19. december 2016
Først indsendt, der opfyldte QC-kriterier
1. februar 2017
Først opslået (Skøn)
3. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2020
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GESIDA 9316
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .