Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: First-line Antiretroviral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infected naive-treatment patients Exclusion Criteria: use of Anti-Retroviral Agents in the past

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Efavirenz Group<br>Naïve-treatment HIV patients, who started therapy with Efavirenz | Drug: First-line Antiretroviral Therapy<br>* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background Efavirenz: 01 capsules day, plus NRTI background<br>* Other names: Kaletra;|
| Active Comparator: Lopinavir/r Group<br>Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir | Drug: First-line Antiretroviral Therapy<br>* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background Efavirenz: 01 capsules day, plus NRTI background<br>* Other names: Kaletra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance HIV RNA <50 copies/mL at the end oh 36 months |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieve HIV RNA <50 copies/mL at the first 6 months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Antiretroviral Therapy, Highly Active, Efavirenz, Lopinavir, Comparative Effectiveness Research, Treatment Naive