Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01049685
First received: January 11, 2010
Last updated: February 12, 2010
Last verified: January 2010

January 11, 2010
February 12, 2010
August 2006
December 2009   (final data collection date for primary outcome measure)
Maintenance HIV RNA <50 copies/mL at the end oh 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01049685 on ClinicalTrials.gov Archive Site
Achieve HIV RNA <50 copies/mL at the first 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: First-line Antiretroviral Therapy
  • Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
  • Efavirenz: 01 capsules day, plus NRTI background
Other Names:
  • Sustiva
  • Kaletra
  • Active Comparator: Efavirenz Group
    Naïve-treatment HIV patients, who started therapy with Efavirenz
    Intervention: Drug: First-line Antiretroviral Therapy
  • Active Comparator: Lopinavir/r Group
    Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
    Intervention: Drug: First-line Antiretroviral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
March 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infected naive-treatment patients

Exclusion Criteria:

  • use of Anti-Retroviral Agents in the past
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01049685
upeclin/HC/FMB-Unesp-38
Yes
Alexandre Naime Barbosa, SAE e Hospital Dia Domingos Alves Meira - Faculdade de Medicina de Botucatu - Unesp
UPECLIN HC FM Botucatu Unesp
Not Provided
Principal Investigator: Alexandre N Barbosa, MD, MSc Botucatu School of Medicine
UPECLIN HC FM Botucatu Unesp
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP