Clinical trial NCT03158077: Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection
Official title: Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks - KIRAL Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients that initiated treatment with RAltegravis + ABC/3TC as a switching strategy

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness: Proportion of patients with undetectable viral load
timeFrame: 48 weeks
Secondary outcomes:
measure: Safety-changes in renal function: changes in creatinine values
timeFrame: 24 weeks following the change
measure: Safety-changes in renal function: changes in glomerular filtration
timeFrame: 24 weeks following the change
measure: Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL
timeFrame: 24 weeks following the change
measure: Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL
timeFrame: 48 weeks following the change
measure: Safety: Changes in serum cholesterol
timeFrame: 24 weeks following the change
measure: Safety: Changes in serum triglycerides
timeFrame: 24 weeks following the change
measure: Safety: Changes in serum cholesterol
timeFrame: 48 weeks following the change
measure: Safety: Changes in serum triglycerides
timeFrame: 48 weeks following the change
measure: Safety: Adverse events.
timeFrame: 24 weeks/48 weeks
measure: Safety:serious adverse events
timeFrame: 24 weeks/48 weeks
measure: Safety: frequency of adverse events leading to discontinuation of treatment.
timeFrame: 24 weeks/48 weeks
measure: Safety: number of deaths
timeFrame: 24 weeks/48 weeks
measure: Safety: frequency of laboratory abnormalities.
timeFrame: 24 weeks/48 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital de Alicante
state: Alcante
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Cartagena
country: Spain
facility: Hospital Santa Lucia
state: Murcia
city: Madrid
country: Spain
facility: Hopital Severo Ochoa
city: MAdrid
country: Spain
facility: Hospital 12 de octubre
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Prícipe de Asturias
city: Madrid
country: Spain
facility: Hospital Ramón y cajal
city: Madrid
country: Spain
facility: Hospital Univ. La Paz
city: Toledo
country: Spain
facility: Complejo hospitalario de Toledo
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
References: