Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection

Completed

• Conditions: HIV Infections

• Registration Number: NCT03158077
• Lead Sponsor: Fundacion SEIMC-GESIDA

Brief Summary

Retrospective observational study, multicentric with Spanish hospitals, in which a switching or change strategy with RAL and ABC / 3TC guidelines was used, in the48 weeks before the start of the study, in order to determine parameters of Effectiveness and security.

Detailed Description

The study consists of a 4-weeks data recording period, during which the follow-up information recorded by physicians in electronic or paper medical history will be analyzed from patients who opted for a change to that study pattern (RAL and ABC / 3TC).

Study Timeline

• Study Start: 2016-11-15
• Primary Completion: 2017-04-20
• Study Completion: 2017-04-20
• Status Verified: 2017-05
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

• Patient with chronic infection with HIV-1.
• Patients older than 18 years.
• Patients in ART in whom RAL + ABC / 3TC has been initiated in at least 48 Weeks prior to the start of the study.
• To have used the RAL + ABC / 3TC as a switching or change strategy
• HIV virological control (CV ≤ 50 copies / ml) for at least 24 weeks prior to initiation of study regimen

Exclusion Criteria

• NAIVE patients who have started treatment with this regimen
• Absence of digital or physical records of visits made for consultation
• Patients who underwent treatment change within 48 weeks prior to study initiation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness: Proportion of patients with undetectable viral load	48 weeks	Effectiveness in the virological control of RAL and ABC / 3TC

Secondary Outcome Measures

Name	Time	Method
Safety: frequency of adverse events leading to discontinuation of treatment.	24 weeks/48 weeks
Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL	48 weeks following the change
Safety-changes in renal function: changes in creatinine values	24 weeks following the change
Safety-changes in renal function: changes in glomerular filtration	24 weeks following the change
Safety: number of deaths	24 weeks/48 weeks
Safety: Changes in serum cholesterol	48 weeks following the change	HDL and LDL cholesterol
Safety: Changes in serum triglycerides	48 weeks following the change
Safety: Adverse events.	24 weeks/48 weeks	Frequency of adverse events
Safety:serious adverse events	24 weeks/48 weeks	Frequency of serious adverse events
Safety: frequency of laboratory abnormalities.	24 weeks/48 weeks

Trial Locations

Locations (14)

Hospital de Alicante; 🇪🇸 Alicante, Alcante, Spain

Hopital Severo Ochoa; 🇪🇸 Madrid, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital 12 de octubre; 🇪🇸 MAdrid, Spain

Hospital Fundación Jimenez Díaz; 🇪🇸 Madrid, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Ramón y cajal; 🇪🇸 Madrid, Spain

Hospital Prícipe de Asturias; 🇪🇸 Madrid, Spain

Complejo hospitalario de Toledo; 🇪🇸 Toledo, Spain

Hospital Rio Hortega; 🇪🇸 Valladolid, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Santa Lucia; 🇪🇸 Cartagena, Murcia, Spain

Hospital Univ. La Paz; 🇪🇸 Madrid, Spain