Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
This trial is active, not recruiting.
|Treatment||first-line antiretroviral therapy|
|Sponsor||UPECLIN HC FM Botucatu Unesp|
|Start date||August 2006|
|End date||December 2009|
|Trial size||36 participants|
|Trial identifier||NCT01049685, upeclin/HC/FMB-Unesp-38|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
time frame: 36 months
Achieve HIV RNA <50 copies/mL at the first 6 months
time frame: 6 months
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - HIV-1 infected naive-treatment patients Exclusion Criteria: - use of Anti-Retroviral Agents in the past
|Official title||Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study|
|Principal investigator||Alexandre N Barbosa, MD, MSc|
|Description||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.|
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