Document Detail


Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients.
MedLine Citation:
PMID:  20672447     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Vicriviroc, an investigational CCR5 antagonist, demonstrated short-term safety and antiretroviral activity.
METHODS: Phase 2, double-blind, randomized study of vicriviroc in treatment-experienced subjects with CCR5-using HIV-1. Vicriviroc (5, 10, or 15 mg) or placebo was added to a failing regimen with optimization of background antiretroviral medications at day 14. Subjects experiencing virologic failure and subjects completing 48 weeks were offered open-label vicriviroc.
RESULTS: One hundred eighteen subjects were randomized. Virologic failure (<1 log10 decline in HIV-1 RNA > or =16 weeks postrandomization) occurred by week 48 in 24 of 28 (86%), 12 of 30 (40%), 8 of 30 (27%), 10 of 30 (33%) of subjects randomized to placebo, 5, 10, and 15 mg, respectively. Overall, 113 subjects received vicriviroc at randomization or after virologic failure, and 52 (46%) achieved HIV-1 RNA <50 copies per milliliter within 24 weeks. Through 3 years, 49% of those achieving suppression did not experience confirmed viral rebound. Dual or mixed-tropic HIV-1 was detected in 33 (29%). Vicriviroc resistance (progressive decrease in maximal percentage inhibition on phenotypic testing) was detected in 6 subjects. Nine subjects discontinued vicriviroc due to adverse events.
CONCLUSIONS: Vicriviroc seems safe and demonstrates sustained virologic suppression through 3 years of follow-up. Further trials of vicriviroc will establish its clinical utility for the treatment of HIV-1 infection.
Authors:
Timothy J Wilkin; Zhaohui Su; Amy Krambrink; Jianmin Long; Wayne Greaves; Robert Gross; Michael D Hughes; Charles Flexner; Paul R Skolnik; Eoin Coakley; Catherine Godfrey; Martin Hirsch; Daniel R Kuritzkes; Roy M Gulick
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  54     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-07-29     Completed Date:  2010-08-12     Revised Date:  2014-09-08    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  470-6     Citation Subset:  IM; X    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00082498
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-HIV Agents / administration & dosage*,  adverse effects*
Female
HIV Infections / drug therapy*
HIV-1 / drug effects*
Humans
Male
Middle Aged
Piperazines / administration & dosage*,  adverse effects*
Placebos / administration & dosage
Pyrimidines / administration & dosage*,  adverse effects*
Treatment Outcome
Viral Load
Grant Support
ID/Acronym/Agency:
AI- 69511/AI/NIAID NIH HHS; AI-25859/AI/NIAID NIH HHS; AI-27661/AI/NIAID NIH HHS; AI-32782/AI/NIAID NIH HHS; AI-34853/AI/NIAID NIH HHS; AI-46370/AI/NIAID NIH HHS; AI-68634/AI/NIAID NIH HHS; AI-69418/AI/NIAID NIH HHS; AI-69419/AI/NIAID NIH HHS; AI-69423/AI/NIAID NIH HHS; AI-69424/AI/NIAID NIH HHS; AI-69432/AI/NIAID NIH HHS; AI-69434/AI/NIAID NIH HHS; AI-69439/AI/NIAID NIH HHS; AI-69450/AI/NIAID NIH HHS; AI-69465/AI/NIAID NIH HHS; AI-69467/AI/NIAID NIH HHS; AI-69471/AI/NIAID NIH HHS; AI-69472/AI/NIAID NIH HHS; AI-69474/AI/NIAID NIH HHS; AI-69494/AI/NIAID NIH HHS; AI-69495/AI/NIAID NIH HHS; AI-69501/AI/NIAID NIH HHS; AI-69502/AI/NIAID NIH HHS; AI-69532/AI/NIAID NIH HHS; AI-69556/AI/NIAID NIH HHS; K23 AI055038-01/AI/NIAID NIH HHS; K23-AI-55038/AI/NIAID NIH HHS; K24 AI051966/AI/NIAID NIH HHS; K24 AI051966-01A1/AI/NIAID NIH HHS; K24-AI-51966/AI/NIAID NIH HHS; M01 RR005280-08/RR/NCRR NIH HHS; M01- RR025780/RR/NCRR NIH HHS; M01-RR00046/RR/NCRR NIH HHS; M01-RR00052/RR/NCRR NIH HHS; M01-RR00096/RR/NCRR NIH HHS; M01-RR024160/RR/NCRR NIH HHS; P30 AI045008/AI/NIAID NIH HHS; P30 AI045008-05/AI/NIAID NIH HHS; P30 AI050410/AI/NIAID NIH HHS; P30 AI050410-04/AI/NIAID NIH HHS; P30-AI-45008/AI/NIAID NIH HHS; P30-AI-50410/AI/NIAID NIH HHS; RR024979/RR/NCRR NIH HHS; U01 AI025859-13/AI/NIAID NIH HHS; U01 AI027661-14/AI/NIAID NIH HHS; U01 AI032782-09/AI/NIAID NIH HHS; U01 AI034853-07/AI/NIAID NIH HHS; U01 AI046370-01/AI/NIAID NIH HHS; U01 AI068634/AI/NIAID NIH HHS; U01 AI068634-01/AI/NIAID NIH HHS; U01 AI068636-01/AI/NIAID NIH HHS; U01 AI069418-01/AI/NIAID NIH HHS; U01 AI069419-01/AI/NIAID NIH HHS; U01 AI069423-01/AI/NIAID NIH HHS; U01 AI069424-01/AI/NIAID NIH HHS; U01 AI069432-01/AI/NIAID NIH HHS; U01 AI069434-01/AI/NIAID NIH HHS; U01 AI069439-01/AI/NIAID NIH HHS; U01 AI069450/AI/NIAID NIH HHS; U01 AI069450-01/AI/NIAID NIH HHS; U01 AI069465-01/AI/NIAID NIH HHS; U01 AI069467-01/AI/NIAID NIH HHS; U01 AI069471-01/AI/NIAID NIH HHS; U01 AI069472-01/AI/NIAID NIH HHS; U01 AI069474-01/AI/NIAID NIH HHS; U01 AI069494-01/AI/NIAID NIH HHS; U01 AI069495-01/AI/NIAID NIH HHS; U01 AI069501-01/AI/NIAID NIH HHS; U01 AI069502-01/AI/NIAID NIH HHS; U01 AI069511-01/AI/NIAID NIH HHS; U01 AI069532/AI/NIAID NIH HHS; U01 AI069532-01/AI/NIAID NIH HHS; U01 AI069556-01/AI/NIAID NIH HHS; U01-AI-68636/AI/NIAID NIH HHS; UL1 RR024160/RR/NCRR NIH HHS; UL1 RR024160-01/RR/NCRR NIH HHS; UL1 RR024979-01/RR/NCRR NIH HHS; UL1 RR024996/RR/NCRR NIH HHS; UL1 RR024996-01/RR/NCRR NIH HHS; UL1 RR025780/RR/NCRR NIH HHS; UL1 RR025780-01/RR/NCRR NIH HHS; UL1-RR024996/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Piperazines; 0/Placebos; 0/Pyrimidines; TL515DW4QS/vicriviroc
Comments/Corrections

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