Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
UPECLIN HC FM Botucatu Unesp
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01049685
First received: January 11, 2010
Last updated: February 12, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: First-line Antiretroviral Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study |
Resource links provided by NLM:
Further study details as provided by UPECLIN HC FM Botucatu Unesp:
Primary Outcome Measures:
- Maintenance HIV RNA <50 copies/mL at the end oh 36 months [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Achieve HIV RNA <50 copies/mL at the first 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 36 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Efavirenz Group
Naïve-treatment HIV patients, who started therapy with Efavirenz
|
Drug: First-line Antiretroviral Therapy
Other Names:
|
|
Active Comparator: Lopinavir/r Group
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
|
Drug: First-line Antiretroviral Therapy
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 infected naive-treatment patients
Exclusion Criteria:
- use of Anti-Retroviral Agents in the past
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01049685
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049685
Locations
| Brazil | |
| SAE e Hospital Dia Domingos Alves Meira | |
| Botucatu, SP, Brazil, 18603-790 | |
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
| Principal Investigator: | Alexandre N Barbosa, MD, MSc | Botucatu School of Medicine |
More Information
| 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 |
| Study First Received: | January 11, 2010 |
| Last Updated: | February 12, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
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 |
ClinicalTrials.gov processed this record on September 27, 2016