Clinical trial NCT03042390: Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
Official title: Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag, S.A.
First posted: 2017-02-03
Enrollment: 762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

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 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.

Primary outcomes:
measure: Virological effectiveness data: Percentage of patients with undetectable viral load
timeFrame: 24 weeks
measure: Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
timeFrame: 24 weeks
measure: Virological effectiveness data: time to loss of virological efficacy.
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 48 weeks
measure: Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
timeFrame: 48 weeks
measure: Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).
timeFrame: Basal and 24 weeks/48 weeks
measure: Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.
timeFrame: basal and 24 weeks/48 weeks
measure: Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT
timeFrame: basal and 24 weeks/48 weeks
measure: Tolerability data:Rate of patients discontinuing treatment for toxicity.
timeFrame: 24 weeks/48 weeks
measure: Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks
timeFrame: 24 weeks/48 weeks
measure: 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.
timeFrame: 24 weeks/48 weeks
measure: 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)
timeFrame: 24 weeks / 48 weeks
measure: Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen
timeFrame: 24 weeks / 48 weeks
measure: 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)
timeFrame: 24 weeks / 48 weeks
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Costa del Sol
state: Marbella
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital del Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Guadalajara
country: Spain
facility: Hospital de Guadalajara
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Príncipe de Asturias
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Llatzer
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Vigo
country: Spain
facility: Complejo Hospitalaria Alvaron Cunqueiro
Study officials:
References:
citation: 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.
citation: 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.