Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
First-line Antiretroviral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Antiretroviral Therapy, Highly Active, Efavirenz, Lopinavir, Comparative Effectiveness Research, Treatment Naive
Eligibility Criteria
Inclusion Criteria:
- HIV-1 infected naive-treatment patients
Exclusion Criteria:
- use of Anti-Retroviral Agents in the past
Sites / Locations
- SAE e Hospital Dia Domingos Alves Meira
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Efavirenz Group
Lopinavir/r Group
Arm Description
Naïve-treatment HIV patients, who started therapy with Efavirenz
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
Outcomes
Primary Outcome Measures
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
Secondary Outcome Measures
Achieve HIV RNA <50 copies/mL at the first 6 months
Full Information
NCT ID
NCT01049685
First Posted
January 11, 2010
Last Updated
February 12, 2010
Sponsor
UPECLIN HC FM Botucatu Unesp
1. Study Identification
Unique Protocol Identification Number
NCT01049685
Brief Title
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
Official Title
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Antiretroviral Therapy, Highly Active, Efavirenz, Lopinavir, Comparative Effectiveness Research, Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Efavirenz Group
Arm Type
Active Comparator
Arm Description
Naïve-treatment HIV patients, who started therapy with Efavirenz
Arm Title
Lopinavir/r Group
Arm Type
Active Comparator
Arm Description
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
First-line Antiretroviral Therapy
Other Intervention Name(s)
Sustiva, Kaletra
Intervention Description
Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
Efavirenz: 01 capsules day, plus NRTI background
Primary Outcome Measure Information:
Title
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Achieve HIV RNA <50 copies/mL at the first 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 infected naive-treatment patients
Exclusion Criteria:
use of Anti-Retroviral Agents in the past
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre N Barbosa, MD, MSc
Organizational Affiliation
Botucatu School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAE e Hospital Dia Domingos Alves Meira
City
Botucatu
State/Province
SP
ZIP/Postal Code
18603-790
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
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