HIV Infections
Conditions
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).
Interventions
None listed
Sponsors
Fundacion SEIMC-GESIDA
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Proportion of patients with undetectable viral load | 48 weeks | Effectiveness in the virological control of RAL and ABC / 3TC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Changes in serum triglycerides | 24 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 adverse events leading to discontinuation of treatment. | 24 weeks/48 weeks | — |
| Safety: Changes in serum cholesterol | 24 weeks following the change | HDL and LDL cholesterol |
| Safety: frequency of laboratory abnormalities. | 24 weeks/48 weeks | — |
| 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: Changes in serum levels of AST, ALT, FA, GGT and BIL | 24 weeks following the change | — |
| Safety: number of deaths | 24 weeks/48 weeks | — |
Countries
Spain
Outcome results
None listed