LB-2. 48-Week Safety and Efficacy of Maraviroc, a Novel CCR5 Antagonist, in Combination with Optimized Background Therapy (OBT) for the Treatment of Antiretroviral-Experienced Patients Infected with Dual/Mixed-Tropic HIV-1
Session: Symposia: Late Breaker Symposium
Friday, October 5, 2007: 12:00 AM
Room: 28A-E
Background Maraviroc (MVC) is a CCR5 antagonist active against R5 but not X4 or dual-tropic HIV-1. A Phase 2b study was performed to evaluate safety and efficacy of MVC vs placebo (PBO), combined with OBT, in patients with dual- or mixed-tropic (D/M) HIV-1.

Methods A4001029 is a double-blind, PBO-controlled trial. Patients on a stable ARV regimen with HIV-1 RNA ≥5000 c/mL, without R5 virus exclusively, and 3-class experience and/or 2-class resistant virus were randomized (1:1:1) to 1 of 3 groups for 48 wks: OBT + PBO or MVC QD or BID.

Results 167 patients had D/M virus at screening. Median CD4 count was <50 cells/mm3 and mean viral load (VL) was >5 log c/mL for each study arm at baseline.
A4001029: Summary of 48 wk results (all randomized, treated patients with D/M virus at screening)
At Week 48:

PBO + OBT

(n=58)

MVC QD + OBT (n=57)MVC BID + OBT (n=52)
Mean change in HIV-1 RNA from baseline, log10 c/mL / Treatment difference vs PBO (97.5% CI)–0.84 / N/A–0.62 / +0.23 (–0.35, +0.81)–1.11 / –0.26 (–0.86, +0.33)
% with HIV-1 RNA <400 c/mL (p-value vs PBO) Bonaventura Clotet, MD1, Elna van der Ryst2, Gerd Fätkenheuer3, Howard Mayer2, James Goodrich, PhD, MD4, Karen Turner2, Mike Saag5, Mike Westby2, Nathan Clumeck6 and   J.M. Goodrich, Pfizer; Annual Salary; M. Saag, Achillion Pharmaceutical; Avexa; Boehringer-Ingelheim; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline; Merck; Monogram Biosciences; Panacos; Pfizer / Agouron; Progenics; Roche Laboratories; Tanox; Tibotec / Virco; Trimeris; Vertex; Consultantancy fees; Achillion Pharmaceutica; Boehringer-Ingelheim; Gilead Sciences; GlaxoSmithKline; Merck; Panacos; Pfizer / Agouron; Progenics; Roche Laboratories; Serono; Tibotec; Trimeris; Vertex; Grant / Research Support; E. van der Ryst, Pfizer; Annual Salary; G. Fätkenheuer, Pfizer; Schering Plough; Honoraria; Pfizer; Schering Plough; Honoraria; B. Clotet, Gilead; Roche; Bristol Myers Squibb; GlaxoSmithKline; Tibotec-Jansen; Boehringer Ingelheim; Pfizer; Abbot; Merck; Panacos; Consulting fees; Gilead; Roche; Bristol Myers Squibb; GlaxoSmithKline; Tibotec-Jansen; Boehringer Ingelheim; Pfizer; Abbot; Merck; Panacos; Lecture fees; N. Clumeck, Abbott; Boehringer; Merck Sharp & Dohme; Roche; GlaxoSmithKline; Tibotec; Consulting Fees; Abbott; Boehringer; Merck Sharp & Dohme; Roche; GlaxoSmithKline; Tibotec; A fee for speaking and organising education; Abbott; Boehringer; Merck Sharp & Dohme; Roche; GlaxoSmithKline; Tibotec; Research Funds; K. Turner, Previous Pfizer Employee; Annual Salary was received; M. Westby, Pfizer; Annual salary; H. Mayer, Pfizer; Annual salary., (1)Hospital Germans Trias i Pujol, Barcelona, Spain, (2)Pfizer Global Res. and Dev., (3)Univ. of Cologne, (4)Pfizer Global Res. and Dev., New London, CT, (5)Univ. of Alabama, (6)St Pierre Univ. Hosp.

Anita R. Rachlis, MD, MEd, FRCPC
Dr. Rachlis is an ID consultant and Medical Director of the HIV Ambulatory Clinic at Sunnybrook Health Sciences Centre, University of Toronto.
Prior to her regional appointment as Associate Director, Ontario Region, Canadian HIV Trials Network, Dr. Rachlis worked with the CTN from its inception in 1990 as a principal investigator at the Sunnybrook Health Sciences Centre satellite site, and as a Scientific Review Committee member. She has consistently promoted and participated in HIV clinical research in Ontario.
Since 1986, Dr. Rachlis has served on numerous editorial, medical and advisory AIDS committees, including the Ontario AIDS Advisory Committee, Ontario HIV Treatment Network and Health Canada's Expert Advisory Committee on HIV Therapies. She was appointed to the Ministerial Council on HIV/AIDS in September 2003 and continues as an active member and Council representative to the CIHR HIV/AIDS Research Advisory Committee.
Dr. Rachlis has been involved in a number of clinical trials involving anti-retroviral agents and management of opportunistic infections.
Along with these affiliations and responsibilities, Dr. Rachlis is a Professor in the Department of Medicine at the University of Toronto. She has a strong interest in medical education as Clerkship Director, Undergraduate Medical Program, University of Toronto, and earned her Master of Education from the Ontario Institute of Studies in Education in 1994. She served as a member of the executive council of the Canadian Association of HIV/AIDS Research and chaired the Association's 1994 conference in Toronto.



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