Document Detail


Early virologic rebound in a pilot trial of ritonavir-boosted atazanavir as maintenance monotherapy.
MedLine Citation:
PMID:  17159658     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To investigate the feasibility of ritonavir-boosted atazanavir monotherapy in HIV-1-infected patients with stable antiretroviral therapy (ART). DESIGN: Single-armed single-center pilot trial. METHODS: Adult HIV-1-infected patients, without protease inhibitor (PI) experience, were eligible if they had maintained a viral load <20 copies/mL for a minimum of 12 months on conventional ART. The trial regimen was atazanavir/ritonavir at a dose of 300/100 mg once daily. The atazanavir dose could be adjusted if plasma concentrations showed a low exposure. The study was intended to recruit 30 patients to be followed over 72 weeks. If 5 cases of virologic failure occurred during this period, the study was to be terminated. RESULTS: The study was terminated according to protocol when 15 of the planned 30 patients had been recruited, because 5 cases of virologic failure had occurred. In patients failing therapy, viral rebound was seen at weeks 12 through 16. Plasma atazanavir concentrations were not associated with the outcome. The median serum bilirubin concentration was significantly lower in the patients failing therapy, however. No PI resistance was found in samples from patients failing therapy. CONCLUSIONS: Ritonavir-boosted atazanavir as maintenance monotherapy in HIV-1 infection might not be as potent as conventional ART. Serum bilirubin should be further studied as a biomarker of adequate atazanavir exposure.
Authors:
Olle Karlström; Filip Josephson; Anders Sönnerborg
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  44     ISSN:  1525-4135     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-03-13     Completed Date:  2007-07-10     Revised Date:  2007-11-19    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  417-22     Citation Subset:  IM; X    
Affiliation:
Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden. ollekarlstrom@ki.se
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MeSH Terms
Descriptor/Qualifier:
Adult
Bilirubin / analysis
CD4 Lymphocyte Count
Drug Administration Schedule
Female
HIV Infections / blood,  drug therapy*,  immunology
HIV Protease Inhibitors / administration & dosage,  pharmacokinetics,  therapeutic use
HIV-1 / drug effects*,  genetics
Humans
Male
Middle Aged
Oligopeptides / administration & dosage,  pharmacokinetics,  therapeutic use*
Pilot Projects
Pyridines / administration & dosage,  pharmacokinetics,  therapeutic use*
RNA, Viral / blood
Ritonavir / administration & dosage,  pharmacokinetics,  therapeutic use*
Time Factors
Treatment Outcome
Viral Load
Chemical
Reg. No./Substance:
0/HIV Protease Inhibitors; 0/Oligopeptides; 0/Pyridines; 0/RNA, Viral; 0/Ritonavir; 198904-31-3/atazanavir; 635-65-4/Bilirubin
Comments/Corrections
Comment In:
J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):118; author reply 118-9   [PMID:  17909317 ]

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


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