16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

ACTG 5211: PHASE II STUDY OF THE SAFETY AND EFFICACY OF VICRIVIROC IN HIV-INFECTED TREATMENT-EXPERIENCED SUBJECTS

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. ThLB0217

Gulick R.¹, Su Z.², Flexner C.³, Hughes M.², Skolnik P.⁴, Godfrey C.⁵, Greaves W.⁶, Wilkin T.¹, Gross R.⁷, Coakley E.⁸, Zolopa A.⁹, Hirsch M.¹⁰, Kuritzkes D.¹⁰, for the ACTG 5211 Study Team
¹Cornell University, New York, United States, ²Harvard School of Public Health, Boston, United States, ³Johns Hopkins University Hospital, Baltimore, United States, ⁴Boston University Medical Center, Boston, United States, ⁵Division of AIDS, NIH, Bethesda, United States, ⁶Schering-Plough Research Institute, Kenilworth, United States, ⁷University of Pennsylvania School of Medicine, Philadelphia, United States, ⁸Monogram Biosciences, Inc., South San Francisco, United States, ⁹Stanford University, Palo Alto, United States, ¹⁰Harvard Medical School, Boston, United States

BACKGROUND: Vicriviroc is an investigational CCR5 inhibitor with potent short-term antiretroviral activity.

METHODS: Double-blind, randomized, 48-week study of vicriviroc in treatment-experienced patients taking ritonavir-containing regimens with R5-tropic virus (Monogram assay) and HIV-1 RNA (VL) ≥5000 copies/ml. Vicriviroc at 5, 10, or 15 mg daily (or placebo) was given for 14 days; then background antiretrovirals were optimized. Virologic failure was defined as confirmed VL <1 log₁₀ copies/ml below baseline at/after week 16; post-failure cross-over to vicriviroc was permitted. Primary endpoint was change in VL at day 14. The 5 mg dose was discontinued early following recommendation from the Study Monitoring Committee and the study was unblinded following reports of 5 malignancies. Data for blinded study period are presented; open-label follow-up continues.

RESULTS: 118 patients were randomized (8% women; 34% non-whites) with median VL 36380 (4.56 log₁₀) copies/ml and CD4 146 cells/µL.

HIV-1 RNA decrease was greater in each vicriviroc group than placebo at day 14 and week 24 (P<0.01) and not different between vicriviroc groups (P>0.05)(ITT). Grade 3/4 adverse events were similar across groups. Among vicriviroc patients, 2 developed Hodgkin´s disease (HD)(one with prior HD); 2 non-Hodgkin´s lymphoma (one with prior HD); and 1 gastric adenocarcinoma.

CONCLUSIONS: In treatment-experienced patients, vicriviroc demonstrated potent 14-day virologic suppression and, following optimization of background antiretrovirals, sustained antiretroviral activity over 24 weeks. The relationship of vicriviroc to malignancy is uncertain.

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2006-08-13
ThLB0217

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