Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

NCT ID: NCT01049685

Last Updated: 2010-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-03-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Efavirenz Group

Naïve-treatment HIV patients, who started therapy with Efavirenz

Group Type: ACTIVE_COMPARATOR

First-line Antiretroviral Therapy

Intervention Type: DRUG

• Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
• Efavirenz: 01 capsules day, plus NRTI background

Lopinavir/r Group

Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir

Group Type: ACTIVE_COMPARATOR

First-line Antiretroviral Therapy

Intervention Type: DRUG

• Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
• Efavirenz: 01 capsules day, plus NRTI background

Interventions

First-line Antiretroviral Therapy

• Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
• Efavirenz: 01 capsules day, plus NRTI background

Intervention Type: DRUG

Other Intervention Names

Sustiva; Kaletra

Eligibility Criteria

Inclusion Criteria

• HIV-1 infected naive-treatment patients

Exclusion Criteria

• use of Anti-Retroviral Agents in the past

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Responsible Party

SAE e Hospital Dia Domingos Alves Meira - Faculdade de Medicina de Botucatu - Unesp

Principal Investigators

Alexandre N Barbosa, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Botucatu School of Medicine

Locations

SAE e Hospital Dia Domingos Alves Meira

Botucatu, São Paulo, Brazil

Countries

Brazil

Other Identifiers

upeclin/HC/FMB-Unesp-38

Identifier Type: -

Identifier Source: org_study_id