Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment first-line antiretroviral therapy
Phase phase 4
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Naïve-treatment HIV patients, who started therapy with Efavirenz
first-line antiretroviral therapy Sustiva
Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background Efavirenz: 01 capsules day, plus NRTI background
(Active Comparator)
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
first-line antiretroviral therapy Sustiva
Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background Efavirenz: 01 capsules day, plus NRTI background

Primary Outcomes

Measure
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
time frame: 36 months

Secondary Outcomes

Measure
Achieve HIV RNA <50 copies/mL at the first 6 months
time frame: 6 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by UPECLIN HC FM Botucatu Unesp.