A Phase 4 interventional study of First-line Antiretroviral Therapy in HIV Infections, sponsored by UPECLIN HC FM Botucatu Unesp. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-15.
Sponsored by UPECLIN HC FM Botucatu Unesp · Phase 4, Interventional, and Treatment
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.
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 36 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →UPECLIN HC FM Botucatu Unesp is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Naïve-treatment HIV patients, who started therapy with Efavirenz
Drug: First-line Antiretroviral Therapy
Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir
Drug: First-line Antiretroviral Therapy
* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background * Efavirenz: 01 capsules day, plus NRTI background
Also known as: Sustiva, Kaletra
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
This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efavirenz
UPECLIN HC FM Botucatu Unesp