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Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

Information source: UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: First-line Antiretroviral Therapy (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: UPECLIN HC FM Botucatu Unesp

Official(s) and/or principal investigator(s):
Alexandre N Barbosa, MD, MSc, Principal Investigator, Affiliation: Botucatu School of Medicine

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maintenance HIV RNA <50 copies/mL at the end oh 36 months

Secondary outcome: Achieve HIV RNA <50 copies/mL at the first 6 months

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV-1 infected naive-treatment patients

Exclusion Criteria:

- use of Anti-Retroviral Agents in the past

Locations and Contacts

SAE e Hospital Dia Domingos Alves Meira, Botucatu, SP 18603-790, Brazil
Additional Information

Starting date: August 2006
Last updated: February 12, 2010

Page last updated: August 23, 2015

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