NCT01049685

Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: UPECLIN HC FM Botucatu Unesp · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	First-line Antiretroviral Therapy	* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background * Efavirenz: 01 capsules day, plus NRTI background

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2010-01-14
• Last updated: 2010-02-15

Locations

1 site across 1 country: Brazil