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Sponsors and Collaborators: |
Schering-Plough Bristol-Myers Squibb |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00551018 |
Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected treatment-naïve subjects.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Vicriviroc Drug: emtricitabine and tenofovir disoproxil fumarate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Vicriviroc + Reyataz + ritonavir: Experimental
vicriviroc 30 mg tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD
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Drug: Vicriviroc
one 30 mg tablet QD
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Truvada® + Reyataz + ritonavir: Active Comparator
Truvada® 200/300 combination tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD
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Drug: emtricitabine and tenofovir disoproxil fumarate
one 200/300 combination tablet QD
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This is a randomized, open-label, active-controlled, parallel-group, multi-center study of vicriviroc maleate in treatment-naïve subjects infected with CCR5-tropic HIV. The study will compare the virologic benefit of vicriviroc combined with ritonavir-boosted Reyataz to a control group receiving Truvada plus ritonavir-boosted Reyataz. Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. Interim analyses will be performed when the first cohort of 80 subjects have completed 24 weeks and 48 weeks of treatment. The second cohort of 120 subjects will be enrolled after the first interim analysis. If vicriviroc at the dose studied proves to be safe and efficacious, study participants who successfully complete 48 weeks of treatment or for whom vicriviroc is medically appropriate will be offered vicriviroc free of charge until the drug is commercially available.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
United States, California | |
Investigational Site 22 | Recruiting |
Palm Springs, California, United States, 92262 | |
United States, Florida | |
Investigational Site 18 | Recruiting |
Orlando, Florida, United States, 32803 | |
United States, New Jersey | |
Investigational Site 20 | Recruiting |
Newark, New Jersey, United States, 07102 | |
United States, New York | |
Investigational Site 24 | Recruiting |
Bronx, New York, United States, 10467 | |
United States, Texas | |
Investigational Site 19 | Recruiting |
Houston, Texas, United States, 77004 | |
Investigational Site 23 | Recruiting |
Houston, Texas, United States, 77009 | |
Germany | |
Investigational Site 7 | Recruiting |
Koeln, Germany, 50937 | |
Guatemala | |
Investigational Site 14 | Active, not recruiting |
Guatemala, Guatemala, 01009 | |
Honduras | |
Investigational Site 15 | Active, not recruiting |
San Pedro Sula, Honduras | |
Italy | |
Investigational Site 9 | Recruiting |
Milano, Italy, 20127 | |
Investigational Site 8 | Recruiting |
Brescia, Italy, 25123 | |
Investigational Site 10 | Recruiting |
Milano, Italy | |
Portugal | |
Investigational Site 13 | Recruiting |
Porto, Portugal, 4369-004 | |
Investigational Site 12 | Recruiting |
Lisboa, Portugal, 1649-035 | |
South Africa | |
Investigational Site 1 | Recruiting |
Meadowdale, Edenvale G, South Africa, 1610 | |
Investigational Site 2 | Recruiting |
Johannesburg, South Africa | |
Investigational Site 3 | Recruiting |
Westdene, Johannesburg, South Africa, 2042 | |
Investigational Site 4 | Recruiting |
Observatory, Cape Town, South Africa, 7925 | |
Investigational Site 5 | Recruiting |
Parow, Cape Town, South Africa, 7505 | |
Spain | |
Investigational Site 17 | Recruiting |
Badalona, Spain, 08916 | |
Investigational Site 16 | Recruiting |
Barcelona, Spain, 08036 |
Study Director: | Michael McCarthy, MD | Schering-Plough |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04875 |
Study First Received: | October 29, 2007 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00551018 |
Health Authority: | United States: Food and Drug Administration |
Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |