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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: Final results of two randomized phase III trials
Journal of Infection, Volume 65, No. 4, Year 2012
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Description
Background: Vicriviroc, a novel HIV CCR5 antagonist, demonstrated significant efficacy and favorable tolerability in phase II trials in treatment-experienced subjects, supporting further evaluation in phase III studies. Methods: Two identical double-blind, placebo (PBO)-controlled trials in CCR5-tropic HIV-infected subjects with documented resistance to two antiretroviral classes were conducted. Subjects were randomized to vicriviroc 30 mg QD (N = 571) or PBO (N = 286) with open-label optimized background therapy (OBT) containing ≥2 fully active antiretroviral drugs. The primary endpoint was percentage of subjects with <50 copies/mL HIV RNA at 48 weeks. It was analyzed in a logistic regression with treatment (vicriviroc + OBT/PBO + OBT), use of enfuvirtide in baseline OBT (yes/no), and baseline HIV RNA (≤100,000/>100,000 copies/mL) as covariates. In addition, a pre-planned analysis to examine other efficacy and safety endpoints was conducted. Results: Baseline characteristics of the pooled mITT population (vicriviroc, n = 486; PBO, n = 235) included mean HIV RNA of 4.6 log10 copies/mL and mean CD4 count of 257 cells/μL. Approximately 60% of subjects received ≥3 active drugs in the OBT. The percentage of subjects with <50 copies/mL HIV RNA was not significantly different between vicriviroc and PBO at week 48 (64% vs 62%, p = 0.6). However, in subjects receiving ≤2 active drugs in their OBT, the proportion achieving <50 copies/mL HIV RNA was higher in those receiving vicriviroc compared with PBO (70% vs 55%, p = 0.02). Conclusions: The studies failed to show significant efficacy gains when vicriviroc was added to OBT. However, given the efficacy results of earlier vicriviroc trials and other CCR5 antagonist, studies are needed to define the role of this class of drugs in the treatment of HIV.Clinical trial identifier: http://www.clinicaltrial.gov/: VICTOR-E3 (NCT00523211) and VICTOR-E4 (NCT00474370). © 2012 The British Infection Association.
Authors & Co-Authors
Caseiro, Marcos Montani
Unknown Affiliation
Nelson, Mark Richard
Unknown Affiliation
Diaz, Ricardo Sobhie
Unknown Affiliation
Gathe, Joseph Clayton
Unknown Affiliation
de Andrade Neto, Jose L.
Unknown Affiliation
Slim, Jihad
Unknown Affiliation
Solano, Antonio
Unknown Affiliation
Martins Netto, Eduardo Martins
Unknown Affiliation
Mak, Carmen
Unknown Affiliation
Shen, Junwa
Unknown Affiliation
Greaves, Wayne L.
Unknown Affiliation
Dunkle, Lisa M.
Unknown Affiliation
Vilchez, Regis A.
Unknown Affiliation
Zeinecker, Jennifer
Unknown Affiliation
Statistics
Citations: 34
Authors: 14
Affiliations: 11
Identifiers
Doi:
10.1016/j.jinf.2012.05.008
ISSN:
01634453
e-ISSN:
15322742
Research Areas
Disability
Infectious Diseases
Study Design
Cross Sectional Study