Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

HIV Infections Clinical Trial

Official title:

Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01049685
• Other study ID #: upeclin/HC/FMB-Unesp-38
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 11, 2010
• Last updated: February 12, 2010
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: January 2010
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• HIV-1 infected naive-treatment patients

Exclusion Criteria:

• use of Anti-Retroviral Agents in the past

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• First-line Antiretroviral Therapy
Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background Efavirenz: 01 capsules day, plus NRTI background

Locations

Country	Name	City	State
Brazil	SAE e Hospital Dia Domingos Alves Meira	Botucatu	SP

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance HIV RNA <50 copies/mL at the end oh 36 months		36 months	Yes
Secondary	Achieve HIV RNA <50 copies/mL at the first 6 months		6 months	Yes