HIV Infections Clinical Trial
Official title:
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study.
Background: Either LPV/r or EFZ plus a two nucleoside reverse-transcriptase inhibitors
(NRTIs) are recommended by the current guidelines all around the world as the main
background drugs for initial therapy of human immunodeficiency virus type 1 (HIV-1)
infection. This indication is based in results of clinical trials, but patients who
participate in these studies usually are greatly motivated to continue their prescribed
regimen, and can be different from the "real life". Therefore, clinical practice often
cannot reproduce published results.
Methods: A retrospective longitudinal cohort study was performed with 36 naïve-treatment
patients, who started therapy with LPV/r or EFZ, with follow-up of 36 months. The primary
endpoint was virological success (HIV RNA <50 copies/mL) in the first six months and at the
end of the study. Effectiveness was examined comparing time to virological failure and CD4
recovery.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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