Document Detail


Efficacy and tolerability of a nucleoside reverse transcriptase inhibitor-sparing combination of lopinavir/ritonavir and efavirenz in HIV-1-infected patients.
MedLine Citation:
PMID:  15980689     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Recommended antiretroviral regimens include a nucleoside reverse transcriptase inhibitor (NRTI) component. Class cross-resistance and mitochondrial toxicity are recognized as problems with this class of antiretrovirals.
METHODS: In a pilot open-label study, 65 antiretroviral-naive and 21 experienced but nonnucleoside reverse transcriptase inhibitor-naive HIV-1-infected adults were given a combination of lopinavir/ritonavir (533.3/133.3 mg twice daily) and efavirenz (600 mg once daily) for 48 weeks.
RESULTS: At baseline, the mean viral load was 4.84 log10 copies/mL and the mean CD4 count was 311 cells/mm. At week 24, the proportions of patients with a viral load <400 copies/mL were 78% and 93% using an intent-to-treat and on-treatment analysis, respectively. At week 48, proportions were 73% and 97%, respectively. Treatment discontinuation occurred in 21 patients during the 48-week period, with 33% of those attributable to drug-related adverse effects. A viral load >400 copies/mL at week 24 or 48 was associated with nonadherence in 3 patients and virologic failure in 1 patient. After an increase during the first 8 weeks, fasting lipid levels remained stable up to 48 weeks.
CONCLUSION: The lopinavir/ritonavir-efavirenz combination is associated with a high rate of virologic response and should be compared with more classic NRTI-containing regimens in randomized and controlled clinical trials.
Authors:
Clotilde Allavena; Virginie Ferré; Cécile Brunet-François; Jean-François Delfraissy; Alain Lafeuillade; Marc-Antoine Valantin; Michelle Bentata; Christian Michelet; Isabelle Poizot-Martin; Eric Dailly; Odile Launay; François Raffi;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  39     ISSN:  1525-4135     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2005 Jul 
Date Detail:
Created Date:  2005-06-27     Completed Date:  2005-09-13     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  300-6     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Anti-HIV Agents / administration & dosage*,  adverse effects
Antiretroviral Therapy, Highly Active
Benzoxazines
CD4 Lymphocyte Count
Drug Resistance, Viral / genetics
Drug Tolerance
Female
France
Genotype
HIV Infections / drug therapy*,  immunology,  virology
HIV Protease Inhibitors / administration & dosage,  adverse effects
HIV-1* / drug effects,  genetics
Humans
Lopinavir
Male
Middle Aged
Oxazines / administration & dosage*,  adverse effects,  blood
Prospective Studies
Pyrimidinones / administration & dosage*,  adverse effects,  blood
RNA, Viral / blood
Reverse Transcriptase Inhibitors / administration & dosage,  adverse effects
Ritonavir / administration & dosage*,  adverse effects
Safety
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Benzoxazines; 0/HIV Protease Inhibitors; 0/Oxazines; 0/Pyrimidinones; 0/RNA, Viral; 0/Reverse Transcriptase Inhibitors; 2494G1JF75/Lopinavir; JE6H2O27P8/efavirenz; O3J8G9O825/Ritonavir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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