Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: Final results of two randomized phase III trials

Caseiro, Marcos Montani; Nelson, Mark; Diaz, Ricardo Sobhie; Gathe, Joseph; Neto, José L. de Andrade; Slim, Jihad; Solano, Antonio Manzano; Netto, Eduardo Martins; Mak, Carmen; Shen, Junwa; Greaves, Wayne; Dunkle, Lisa M.; Vilchez, Regis A.; Zeinecker, Jennifer

doi:10.1016/j.jinf.2012.05.008

Cited by 36 publications

(34 citation statements)

References 13 publications

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“…In addition, the agents that mimic the ligands of CCR5 can block HIV entry. For example, Maraviroc and Vicriviroc, the selective CCR5 antagonists, specifically bind to CCR5 and block cell migration that depends on CCL3, CCL4, CCL5, and CCR5-mediated intracellular signaling (Dorr et al, 2005; Caseiro et al, 2012). As compare with these inhibitors of HIV entry, BBI may have some advantages, as it has low toxicity, minor side-effects and is cost-effective.…”

Section: Discussionmentioning

confidence: 99%

Soybean-derived Bowman-Birk inhibitor (BBI) blocks HIV entry into macrophages

Guo

Zhou

et al. 2018

Virology

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Bowman-Birk inhibitor (BBI) is a soybean-derived protease inhibitor that has anti-inflammation and anti-HIV effect. Here, we further investigated the anti-HIV action of BBI in macrophages, focusing on its effect on viral entry. We found that BBI could significantly block HIV entry into macrophages. Investigation of the mechanism (s) of the BBI action on HIV inhibition showed that BBI down-regulated the expression of CD4 receptor (as much as 80%) and induced the production of the CC chemokines (up to 60 folds at protein level) in macrophages. This inhibitory effect of BBI on HIV entry could be blocked by the neutralization antibodies to CC chemokines. These findings indicate that BBI may have therapeutic potential as a viral entry inhibitor for the prevention and treatment of HIV infection.

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Section: Discussionmentioning

confidence: 99%

Soybean-derived Bowman-Birk inhibitor (BBI) blocks HIV entry into macrophages

Guo

Zhou

et al. 2018

Virology

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“…The number of subjects with 3 or more fully active drugs in the OBT was higher in the VCV trials compared with the MVC trials (55% vs. 32%). 12,16 Thus, more potent OBT regimens may have suppressed outgrowth of pre-existing minor X4-tropic variants. Table 4 VCV phenotypic susceptibility and V3 sequences of gp160 clones from baseline and on-study samples from subjects with VCV resistance.…”

Section: Discussionmentioning

confidence: 99%

“…12 Briefly, 2 identical double-blind multicenter phase 3 studies, VICTOR-E3 (NCT00523211) and VICTOR-E4 (NCT00474370), among treatment experienced subjects compared VCV with placebo, each in combination with optimized background therapy (OBT). Both studies were conducted in accordance with principles of good clinical practice and were approved by the appropriate institutional review boards and regulatory agencies.…”

Section: Study Populationmentioning

confidence: 99%

Detection of HIV-1 CXCR4 tropism and resistance in treatment experienced subjects receiving CCR5 antagonist—Vicriviroc

McNicholas

Vilchez

Greaves

et al. 2012

Journal of Clinical Virology

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“…Given the unique mode of action and use of a host-cell target, initial concerns existed about the potential safety of CCR5 antagonists, including maraviroc 2. Also, early development of other investigational CCR5 antagonists demonstrated potential class-specific effects: aplaviroc was associated with severe hepatotoxicity,3 and further clinical development was stopped; vicriviroc was initially associated with malignancies in a phase 2 study,4 although this was not confirmed in larger phase 3 studies 5…”

Section: Introductionmentioning

confidence: 99%

Five-Year Safety Evaluation of Maraviroc in HIV-1–Infected Treatment-Experienced Patients

Gulick

Fätkenheuer

Burnside

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background Maraviroc is unique among approved antiretroviral drugs in targeting the host-cell CCR5 receptor. With its novel mechanism of action, we sought to describe the 5-year safety profile of maraviroc. Methods Two large phase 3 studies of maraviroc enrolled HIV-infected, treatment-experienced patients and followed them for 5 or more years. Survival and selected clinical endpoints were identified and assessed. Results A total of 938 enrolled patients received maraviroc-containing regimens. Rates of death and selected clinical events (e.g., hepatic failure, malignancy, myocardial infarction) were low during follow-up. Conclusions Maraviroc was generally safe in treatment-experienced participants over more than 5 years.

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Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: Final results of two randomized phase III trials

Cited by 36 publications

References 13 publications

Soybean-derived Bowman-Birk inhibitor (BBI) blocks HIV entry into macrophages

Soybean-derived Bowman-Birk inhibitor (BBI) blocks HIV entry into macrophages

Detection of HIV-1 CXCR4 tropism and resistance in treatment experienced subjects receiving CCR5 antagonist—Vicriviroc

Five-Year Safety Evaluation of Maraviroc in HIV-1–Infected Treatment-Experienced Patients

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