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Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01049685
Enrollment
36
Registered
2010-01-14
Start date
2006-08-31
Completion date
2010-03-31
Last updated
2010-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Antiretroviral Therapy, Highly Active, Efavirenz, Lopinavir, Comparative Effectiveness Research, Treatment Naive

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.

Interventions

DRUGFirst-line Antiretroviral Therapy

* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background * Efavirenz: 01 capsules day, plus NRTI background

Sponsors

UPECLIN HC FM Botucatu Unesp
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* HIV-1 infected naive-treatment patients

Exclusion criteria

* use of Anti-Retroviral Agents in the past

Design outcomes

Primary

MeasureTime frame
Maintenance HIV RNA <50 copies/mL at the end oh 36 months36 months

Secondary

MeasureTime frame
Achieve HIV RNA <50 copies/mL at the first 6 months6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026