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
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