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Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551018
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Vicriviroc Drug: emtricitabine and tenofovir disoproxil fumarate Phase 2

Detailed Description:
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. 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; a third interim analysis will be performed when subjects in this second cohort have completed 24 weeks of treatment. The primary efficacy analysis will be conducted when all 200 subjects from both stages have completed 48 weeks of treatment or discontinued. The final analysis will be performed at Week 96, when all 200 subjects have completed 96 weeks of treatment or discontinued. If vicriviroc is shown to provide benefit at the studied dose, study participants in the vicriviroc arm who complete 96 weeks of treatment may continue in a protocol extension, where they will be offered vicriviroc free of charge until the drug is commercially available in their location or until the sponsor terminates the clinical development of vicriviroc.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects
Study Start Date : December 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Vicriviroc + Reyataz + ritonavir
vicriviroc 30 mg tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD
Drug: Vicriviroc
one 30 mg tablet QD
Other Name: SCH 417690; VCV

Active Comparator: Truvada® + Reyataz + ritonavir
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
Drug: emtricitabine and tenofovir disoproxil fumarate
one 200/300 combination tablet QD
Other Name: Truvada®, a combination of Emtriva® (emtricitabine 200 mg) and Viread® (tenofovir disoproxil fumarate 300 mg); emtricitabine + tenofovir DF; FTC + TDF

Primary Outcome Measures :
  1. Mean change from baseline in log10 HIV RNA [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Proportion of subjects with plasma HIV RNA <50 copies/mL [ Time Frame: Week 48 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult subjects at least 18 years old or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) of either sex or any race with CCR5-tropic HIV infection.
  • Cumulative lifetime anti-retroviral therapy exposure of at most 4 weeks (with the exception of prophylaxis to prevent mother-to-child transmission, and in this case, if no antiretroviral resistance is expected to have developed) and none in the 8 weeks preceding randomization.
  • A CD4 cell count of at least 100 cells/(cubic mm) at Screening (or as specified by local treatment guidelines).
  • HIV ribonucleic acid (RNA) must be at least 2000 copies/mL at Screening.
  • Subjects should meet International AIDS Society (IAS), Department of Health and Human Services (DHSS), or local recommendations for initiation of antiretroviral therapy (ART).
  • Platelet count must be at least 50,000/microL, hemoglobin at least 8 g/dL, absolute neutrophil count at least 1000/microL, serum creatinine <2.0 mg/dL (154 micromol/L), and SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase) at most 3 x upper limit of normal at Screening. Other clinical laboratory tests must be within normal limits or clinically acceptable to the investigator.
  • Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study, or must have been surgically sterilized.
  • Female subjects of childbearing potential must have a negative serum beta-hCG (human chorionic gonadotropin) pregnancy test at Screening and a negative urine beta-hCG pregnancy test on Day 1 prior to dosing.

Exclusion Criteria:

  • Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
  • Subjects with intercurrent illness, vaccinations, or who have used immunomodulators (within the 4 week period prior to randomization) that could influence plasma HIV RNA levels.
  • CXCR4 or dual-mixed (CXCR4 and CCR5) tropism.
  • Subjects with primary resistance mutations to any of proposed components of the study arms.
  • Subjects with active opportunistic infection or malignancy.
  • Subjects with seizure disorder requiring ongoing anti-seizure therapy or with a history of a seizure disorder who are, in the judgment of the investigator, at risk for seizures.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00551018    
Other Study ID Numbers: P04875
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Treatment Naive
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents