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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Efavirenz Ritonavir Lopinavir

U.S. FDA Resources

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:


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 February 27, 2015

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