Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
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ClinicalTrials.gov Identifier: NCT01049685 |
Recruitment Status
: Unknown
Verified January 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was: Active, not recruiting
First Posted
: January 14, 2010
Last Update Posted
: February 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: First-line Antiretroviral Therapy | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | December 2009 |
Estimated Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Efavirenz Group
Naïve-treatment HIV patients, who started therapy with Efavirenz
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Drug: First-line Antiretroviral Therapy
Other Names:
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Active Comparator: Lopinavir/r Group
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
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Drug: First-line Antiretroviral Therapy
Other Names:
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- Maintenance HIV RNA <50 copies/mL at the end oh 36 months [ Time Frame: 36 months ]
- Achieve HIV RNA <50 copies/mL at the first 6 months [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 infected naive-treatment patients
Exclusion Criteria:
- use of Anti-Retroviral Agents in the past

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049685
Brazil | |
SAE e Hospital Dia Domingos Alves Meira | |
Botucatu, SP, Brazil, 18603-790 |
Principal Investigator: | Alexandre N Barbosa, MD, MSc | Botucatu School of Medicine |
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 |
First Posted: | January 14, 2010 Key Record Dates |
Last Update Posted: | February 15, 2010 |
Last Verified: | January 2010 |
Keywords provided by UPECLIN HC FM Botucatu Unesp:
HIV Antiretroviral Therapy, Highly Active Efavirenz |
Lopinavir Comparative Effectiveness Research Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |