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

HIV Infections Clinical Trial

— CoDAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042390
• Other study ID #: GESIDA 9316
• Status: Completed
• Start date: December 23, 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: December 2016
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 762
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
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 Costa del Sol	Malaga	Marbella
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital de Son Llatzer	Palma de Mallorca
Spain	Hospital de Valme	Sevilla
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Complejo Hospitalaria Alvaron Cunqueiro	Vigo

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Janssen-Cilag, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tolerability data:Rate of patients discontinuing treatment for toxicity.	Toxicity to the treatment or virological failure	24 weeks/48 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen		24 weeks / 48 weeks
Secondary	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