Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

Phase 4

• Conditions: HIV Infections
• Interventions: Drug: First-line Antiretroviral Therapy

• Registration Number: NCT01049685
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief 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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-12
• Status Verified: 2010-01
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Last Update Submitted: 2010-02-12
• Last Update Posted: 2010-02-15
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• HIV-1 infected naive-treatment patients

Exclusion Criteria

• use of Anti-Retroviral Agents in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efavirenz Group	First-line Antiretroviral Therapy	Naïve-treatment HIV patients, who started therapy with Efavirenz
Lopinavir/r Group	First-line Antiretroviral Therapy	Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir

Primary Outcome Measures

Name	Time	Method
Maintenance HIV RNA <50 copies/mL at the end oh 36 months	36 months

Secondary Outcome Measures

Name	Time	Method
Achieve HIV RNA <50 copies/mL at the first 6 months	6 months

Trial Locations

Locations (1)

SAE e Hospital Dia Domingos Alves Meira; 🇧🇷 Botucatu, SP, Brazil