Universität zu Köln

Hardy, W. David, Gulick, Roy M., Mayer, Howard, Faetkenheuer, Gerd, Nelson, Mark, Heera, Jayvant, Rajicic, Natasa and Goodrich, James (2010). 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. JAIDS, 55 (5). S. 558 - 565. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1525-4135

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hardy, W. David UNSPECIFIED UNSPECIFIED UNSPECIFIED Gulick, Roy M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mayer, Howard UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Nelson, Mark UNSPECIFIED UNSPECIFIED UNSPECIFIED Heera, Jayvant UNSPECIFIED UNSPECIFIED UNSPECIFIED Rajicic, Natasa UNSPECIFIED UNSPECIFIED UNSPECIFIED Goodrich, James UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-490598
DOI:	10.1097/QAI.0b013e3181ee3d82
Journal or Publication Title:	JAIDS
Volume:	55
Number:	5
Page Range:	S. 558 - 565
Date:	2010
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1525-4135
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language IMMUNODEFICIENCY-VIRUS TYPE-1; CHEMOKINE RECEPTOR CCR5; RHEUMATOID-ARTHRITIS; CLINICAL-TRIALS; REDUCED RISK; ASSOCIATION; DISEASE; POLYMORPHISM; INDIVIDUALS; VICRIVIROC Multiple languages Immunology; Infectious Diseases Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/49059