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

Completed

• Conditions: HIV Infections

• Registration Number: NCT03042390
• Lead Sponsor: Fundacion SEIMC-GESIDA

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

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-19
• Study Start: 2016-12-23
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 762

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virological effectiveness data: Percentage of patients with undetectable viral load	24 weeks	Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA \<50 copies / m.
Virological effectiveness data: time to loss of virological efficacy.	24 weeks	Defined virological failure as two consecutive levels of HIV RNA \> 50 copies / mL or single HIV RNA ≥ 500 copies / mL
Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks	24 weeks	Change in the number of CD4 + T cells at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).	Basal and 24 weeks/48 weeks	Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),
Tolerability data:Rate of patients discontinuing treatment for toxicity.	24 weeks/48 weeks	Toxicity to the treatment or virological failure
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	48 weeks	Virological effectiveness data at 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
Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks	48 weeks	Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells
Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.	basal and 24 weeks/48 weeks	Units: mg/dl or mmol/l
Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT	basal and 24 weeks/48 weeks	GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l
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
Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks	24 weeks/48 weeks	Virological failure defined as two consecutive levels of HIV RNA \> 50 copies / mL or single HIV RNA ≥ 500 copies / mL

Trial Locations

Locations (20)

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 Príncipe de Asturias; 🇪🇸 Madrid, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital de Valme; 🇪🇸 Sevilla, Spain

Hospital Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital de Son Llatzer; 🇪🇸 Palma de Mallorca, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Complejo Hospitalaria Alvaron Cunqueiro; 🇪🇸 Vigo, Spain

Hospital Clinic i Provincial; 🇪🇸 Barcelona, Spain

Hospital Costa del Sol; 🇪🇸 Malaga, Marbella, Spain