Phase 2 Study of the Safety and Efficacy of Vicriviroc, a CCR5 Inhibitor, in HIV-1-Infected, Treatment-Experienced Patients: AIDS Clinical Trials Group 5211
Background. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. Methods. The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)–infected subjects experien...
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| Published in | The Journal of infectious diseases Vol. 196; no. 2; pp. 304 - 312 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
The University of Chicago Press
15.07.2007
University of Chicago Press |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-1899 1537-6613 1537-6613 |
| DOI | 10.1086/518797 |
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| Abstract | Background. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. Methods. The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)–infected subjects experiencing virologic failure while receiving a ritonavir-containing regimen with an HIV-1 RNA level ⩾5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antiretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA level changes at week 24. Results. One hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56 log10) copies/mL and a median CD4 cell count of 146 cells/mm3. At 14 days and 24 weeks, mean changes in HIV-1 RNA level (log10 copies/mL) were greater in the vicriviroc groups (−0.87 and −1.51 [5 mg], −1.15 and −1.86 [10 mg], and −0.92 and −1.68 [15 mg]), than in the placebo group (+0.06 and −0.29) (P<.01). Grade 3/4 adverse events were similar across groups. Malignancies occurred in 6 subjects randomized to vicriviroc and in 2 to placebo. Conclusions. In HIV-1–infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted. |
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| AbstractList | Background. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. Methods. The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)-infected subjects experiencing virologic failure while receiving a ritonavir-containing regimen with an HIV-1 RNA level ⩾5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antiretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA changes at week 24. Results. One hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56$log_{10}$) copies/mL and a median CD4 cell count of 146$cells/mm^{3}$. At 14 days and 24 weeks, mean changes in HIV-1 RNA level ($log_{10}$copies/mL) were greater in the vicriviroc groups (-0.87 and -1.51 [5 mg], -1.15 and -1.86 [10 mg], and -0.92 and -1.68 [15 mg]) than in the placebo group (+0.06 and -0.29) (P < .01). Grade 3/4 adverse events were similar across groups. Malignancies occurred in 6 subjects randomized to vicriviroc and in 2 to placebo. Conclusions. In HIV-1-infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted. Background. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. Methods. The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HlV)-infected subjects experiencing vlrologic fallure while receiving a ritonavlr-containing regimen with an HIV-1 RNA level greater than or equal to 5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antlretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA changes at week 24. Results. One hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56 log10) copies/mL and a median CD4 cell count of 146 cells/mm super(3). At 14 days and 24 weeks, mean changes in HIV-1 RNA level (log10 copies/mL) were greater in the vicriviroc groups (-0.87 and -1.51 [5 mg], -1.15 and -1.86 [10 mg], and -0.92 and -1.68 [15 mg]) than in the placebo group (+0.06 and -0.29) (P < .01). Grade 3/4 adverse events were similar across groups. Malignancles occurred in 6 subjects randomized to vicriviroc and in 2 to placebo. Conclusions. In HIV-1-infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study.BACKGROUNDVicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study.The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)-infected subjects experiencing virologic failure while receiving a ritonavir-containing regimen with an HIV-1 RNA level >or=5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antiretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA changes at week 24.METHODSThe present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)-infected subjects experiencing virologic failure while receiving a ritonavir-containing regimen with an HIV-1 RNA level >or=5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antiretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA changes at week 24.One hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56 log(10)) copies/mL and a median CD4 cell count of 146 cells/mm(3). At 14 days and 24 weeks, mean changes in HIV-1 RNA level (log(10) copies/mL) were greater in the vicriviroc groups (-0.87 and -1.51 [5 mg], -1.15 and -1.86 [10 mg], and -0.92 and -1.68 [15 mg]) than in the placebo group (+0.06 and -0.29) (P<.01). Grade 3/4 adverse events were similar across groups. Malignancies occurred in 6 subjects randomized to vicriviroc and in 2 to placebo.RESULTSOne hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56 log(10)) copies/mL and a median CD4 cell count of 146 cells/mm(3). At 14 days and 24 weeks, mean changes in HIV-1 RNA level (log(10) copies/mL) were greater in the vicriviroc groups (-0.87 and -1.51 [5 mg], -1.15 and -1.86 [10 mg], and -0.92 and -1.68 [15 mg]) than in the placebo group (+0.06 and -0.29) (P<.01). Grade 3/4 adverse events were similar across groups. Malignancies occurred in 6 subjects randomized to vicriviroc and in 2 to placebo.In HIV-1-infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted.CONCLUSIONSIn HIV-1-infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted. Background. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. Methods. The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)–infected subjects experiencing virologic failure while receiving a ritonavir-containing regimen with an HIV-1 RNA level ⩾5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antiretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA level changes at week 24. Results. One hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56 log10) copies/mL and a median CD4 cell count of 146 cells/mm3. At 14 days and 24 weeks, mean changes in HIV-1 RNA level (log10 copies/mL) were greater in the vicriviroc groups (−0.87 and −1.51 [5 mg], −1.15 and −1.86 [10 mg], and −0.92 and −1.68 [15 mg]), than in the placebo group (+0.06 and −0.29) (P<.01). Grade 3/4 adverse events were similar across groups. Malignancies occurred in 6 subjects randomized to vicriviroc and in 2 to placebo. Conclusions. In HIV-1–infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. The present study was a double-blind, randomized phase 2 study of vicriviroc in treatment-experienced, human immunodeficiency virus (HIV)-infected subjects experiencing virologic failure while receiving a ritonavir-containing regimen with an HIV-1 RNA level >or=5000 copies/mL and CCR5-using virus. Vicriviroc at 5, 10, or 15 mg or placebo was added to the failing regimen for 14 days, after which the antiretroviral regimen was optimized. The primary end point was the change in plasma HIV-1 RNA levels at day 14; secondary end points included safety/tolerability and HIV-1 RNA changes at week 24. One hundred eighteen subjects were randomized with a median HIV-1 RNA level of 36,380 (4.56 log(10)) copies/mL and a median CD4 cell count of 146 cells/mm(3). At 14 days and 24 weeks, mean changes in HIV-1 RNA level (log(10) copies/mL) were greater in the vicriviroc groups (-0.87 and -1.51 [5 mg], -1.15 and -1.86 [10 mg], and -0.92 and -1.68 [15 mg]) than in the placebo group (+0.06 and -0.29) (P<.01). Grade 3/4 adverse events were similar across groups. Malignancies occurred in 6 subjects randomized to vicriviroc and in 2 to placebo. In HIV-1-infected, treatment-experienced patients, vicriviroc demonstrated potent virologic suppression through 24 weeks. The relationship of vicriviroc to malignancy is uncertain. Further development of vicriviroc in treatment-experienced patients is warranted. |
| Author | Hirsch, Martin Coakley, Eoin Reichman, Richard Krambrink, Amy Wilkin, Timothy J. Godfrey, Catherine Greaves, Wayne L. Kuritzkes, Daniel R. Skolnik, Paul R. Gulick, Roy M. Gross, Robert Hughes, Michael D. Su, Zhaohui Zolopa, Andrew Flexner, Charles |
| Author_xml | – sequence: 1 givenname: Roy M. surname: Gulick fullname: Gulick, Roy M. email: rgulick@med.cornell.edu organization: Weill Medical College of Cornell UniversityNew York – sequence: 2 givenname: Zhaohui surname: Su fullname: Su, Zhaohui organization: Harvard School of Public HealthBoston, Massachusetts – sequence: 3 givenname: Charles surname: Flexner fullname: Flexner, Charles organization: Johns Hopkins UniversityBaltimore – sequence: 4 givenname: Michael D. surname: Hughes fullname: Hughes, Michael D. organization: Harvard School of Public HealthBoston, Massachusetts – sequence: 5 givenname: Paul R. surname: Skolnik fullname: Skolnik, Paul R. organization: Boston University Medical CenterBoston, Massachusetts – sequence: 6 givenname: Timothy J. surname: Wilkin fullname: Wilkin, Timothy J. organization: Weill Medical College of Cornell UniversityNew York – sequence: 7 givenname: Robert surname: Gross fullname: Gross, Robert organization: University of Pennsylvania School of MedicinePhiladelphia – sequence: 8 givenname: Amy surname: Krambrink fullname: Krambrink, Amy organization: Harvard School of Public HealthBoston, Massachusetts – sequence: 9 givenname: Eoin surname: Coakley fullname: Coakley, Eoin organization: Monogram Biosciences, Inc.South San Francisco – sequence: 10 givenname: Wayne L. surname: Greaves fullname: Greaves, Wayne L. organization: Schering-Plough Research InstituteKenilworth, New Jersey – sequence: 11 givenname: Andrew surname: Zolopa fullname: Zolopa, Andrew organization: Stanford UniversityPalo Alto, California – sequence: 12 givenname: Richard surname: Reichman fullname: Reichman, Richard organization: University of Rochester Medical CenterRochester, New York – sequence: 13 givenname: Catherine surname: Godfrey fullname: Godfrey, Catherine organization: Division of AIDS, National Institutes of HealthBethesda, Maryland – sequence: 14 givenname: Martin surname: Hirsch fullname: Hirsch, Martin organization: Massachusetts General HospitalBoston, Massachusetts – sequence: 15 givenname: Daniel R. surname: Kuritzkes fullname: Kuritzkes, Daniel R. organization: Brigham and Women's Hospital, Harvard Medical SchoolBoston, Massachusetts |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/17570119$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Copyright 2007 Infectious Diseases Society of America |
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| PublicationTitle | The Journal of infectious diseases |
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| Snippet | Background. Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. Methods. The present study was a... Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study. The present study was a double-blind,... Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study.BACKGROUNDVicriviroc, an investigational CCR5... |
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| SubjectTerms | Adult AIDS Anti-Retroviral Agents - adverse effects Anti-Retroviral Agents - therapeutic use Antiretrovirals CCR5 Receptor Antagonists CD4 Lymphocyte Count Clinical trials Dosage Double-Blind Method Drug Therapy, Combination Female HIV 1 HIV Infections - drug therapy HIV Infections - prevention & control HIV-1 - classification HIV-1 - drug effects HIV/AIDS Human immunodeficiency virus 1 Human immunodeficiency virus 2 Humans Male Middle Aged Piperazines - adverse effects Piperazines - therapeutic use Placebos Pyrimidines - adverse effects Pyrimidines - therapeutic use Receptors Ritonavir - therapeutic use RNA RNA, Viral - analysis RNA, Viral - drug effects Viral Load Virology Viruses |
| Title | Phase 2 Study of the Safety and Efficacy of Vicriviroc, a CCR5 Inhibitor, in HIV-1-Infected, Treatment-Experienced Patients: AIDS Clinical Trials Group 5211 |
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