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

NCT ID: NCT03042390

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

762 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-23

Study Completion Date

2017-05-09

Brief Summary

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

Detailed Description

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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

Conditions

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HIV Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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DArunavir/cobicistat

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role collaborator

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Costa del Sol

Málaga, Marbella, Spain

Site Status

Hospital Clinic i Provincial

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital del Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hospital de Guadalajara

Guadalajara, , Spain

Site Status

Hospital Infanta Leonor

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital La Princesa

Madrid, , Spain

Site Status

Hospital Príncipe de Asturias

Madrid, , Spain

Site Status

Hospital Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital de Son Llatzer

Palma de Mallorca, , Spain

Site Status

Hospital de Valme

Seville, , Spain

Site Status

Complejo Hospitalario de Toledo

Toledo, , Spain

Site Status

Hospital Clínico de Valencia

Valencia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Complejo Hospitalaria Alvaron Cunqueiro

Vigo, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33501995 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31236601 (View on PubMed)

Other Identifiers

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GESIDA 9316

Identifier Type: -

Identifier Source: org_study_id

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