Document Detail


Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2.
MedLine Citation:
PMID:  20703158     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Maraviroc, the first approved CCR5 antagonist, demonstrated 48-week safety and virologic efficacy in CCR5-tropic HIV-infected, treatment-experienced patients; however, critical longer-term safety and durability of responses are unknown.
METHODS: Two-year follow-up of 2 prospective, randomized, blinded studies of maraviroc once daily or twice daily, or placebo in treatment-experienced patients with R5-tropic HIV-1 receiving an optimized background regimen. Unblinding occurred after the week-48 visit of the last enrolled patient. Safety and virologic parameters were assessed through week 96.
RESULTS: One thousand forty-nine patients were randomized and received study drugs. HIV-1 RNA was <50 copies per milliliter at week 96 in 39% and 41% of patients receiving maraviroc every day or twice a day, respectively. Among patients with HIV-1 RNA <50 copies per milliliter at week 48, 81% and 87% of patients receiving maraviroc every day or twice a day, respectively, maintained this response at week 96. At week 96, median CD4+ T-cell counts increased from baseline by 89 and 113 cells per cubic millimeter with maraviroc every day and twice a day, respectively. Exposure-adjusted rates of adverse events were similar with maraviroc or placebo. No new or unexpected events were observed after week 48.
CONCLUSIONS: Maraviroc-containing antiretroviral regimens maintained durable responses in treatment-experienced patients with R5 HIV-1 through 96 weeks of treatment with a safety profile similar to placebo.
Authors:
W David Hardy; Roy M Gulick; Howard Mayer; Gerd Fätkenheuer; Mark Nelson; Jayvant Heera; Natasa Rajicic; James Goodrich
Related Documents :
17308738 - Malawi's contribution to "3 by 5": achievements and challenges.
3679588 - Interferon treatment of human genital papillomavirus infection: importance of viral type.
17927618 - A pilot study of 2 years of interferon treatment in patients with chronic delta hepatitis.
10540048 - Interferon alfa-2b alone or in combination with ketoprofen as treatment for interferon-...
25027768 - Short- and long-term efficacy of cholinesterase inhibitors in older adults with alzheim...
16806418 - Percutaneous suprapubic cystolithotripsy under local anesthesia.
Publication Detail:
Type:  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:  55     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2011-09-20     Completed Date:  2011-11-23     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:  558-64     Citation Subset:  IM; X    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00098306;  NCT00098722
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Anti-HIV Agents / therapeutic use
CD4 Lymphocyte Count
CD4-Positive T-Lymphocytes / virology
Cyclohexanes / administration & dosage,  adverse effects*,  therapeutic use*
Double-Blind Method
Female
Follow-Up Studies
HIV Fusion Inhibitors / administration & dosage,  adverse effects*,  therapeutic use*
HIV Infections / drug therapy*,  virology
HIV-1 / drug effects*
Humans
Male
Middle Aged
Receptors, CCR5 / antagonists & inhibitors*
Triazoles / administration & dosage,  adverse effects*,  therapeutic use*
Grant Support
ID/Acronym/Agency:
AI-055032/AI/NIAID NIH HHS; AI-51966/AI/NIAID NIH HHS; K24 AI051966/AI/NIAID NIH HHS; K24 AI051966-06A1/AI/NIAID NIH HHS; K24 AI051966-07/AI/NIAID NIH HHS; K24 AI051966-08/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Cyclohexanes; 0/HIV Fusion Inhibitors; 0/Receptors, CCR5; 0/Triazoles; MD6P741W8A/maraviroc
Comments/Corrections

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


Previous Document:  Population dynamics of HIV-1 subtype B in a cohort of men-having-sex-with-men in Rome, Italy.
Next Document:  A six-week neuromuscular training program for competitive junior tennis players.