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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
  Purpose

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 Intervention Phase
HIV Infections
Drug: First-line Antiretroviral Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Maintenance HIV RNA <50 copies/mL at the end oh 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Achieve HIV RNA <50 copies/mL at the first 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: August 2006
Estimated Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 11, 2010
Last Updated: February 12, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014