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Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

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ClinicalTrials.gov Identifier: NCT01049685
Recruitment Status : Unknown
Verified January 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: First-line Antiretroviral Therapy Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
Study Start Date : August 2006
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Efavirenz Group
Naïve-treatment HIV patients, who started therapy with Efavirenz
 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: Lopinavir/r Group
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
 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


Outcome Measures
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Primary Outcome Measures :
  1. Maintenance HIV RNA <50 copies/mL at the end oh 36 months [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Achieve HIV RNA <50 copies/mL at the first 6 months [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infected naive-treatment patients

Exclusion Criteria:

  • use of Anti-Retroviral Agents in the past
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049685


Locations
Brazil
SAE e Hospital Dia Domingos Alves Meira
Botucatu, SP, Brazil, 18603-790
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Alexandre N Barbosa, MD, MSc Botucatu School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alexandre Naime Barbosa, SAE e Hospital Dia Domingos Alves Meira - Faculdade de Medicina de Botucatu - Unesp
ClinicalTrials.gov Identifier: NCT01049685     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-38
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: January 2010

Keywords provided by UPECLIN HC FM Botucatu Unesp:
HIV
Antiretroviral Therapy, Highly Active
Efavirenz
 Lopinavir
Comparative Effectiveness Research
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers