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Trial record 3 of 14 for:    sch 417690 OR Vicriviroc

Effect of Vicriviroc on HIV Ribonucleic Acid (RNA) Levels in Cerebrospinal Fluid (Study P05241)

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: NCT00632073
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : February 23, 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 studies in HIV treatment-experienced patients have shown that vicriviroc is safe and effective. The purpose of this study is to determine the effect of vicriviroc on HIV RNA levels in cerebrospinal fluid (CSF).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Vicriviroc Phase 1

Detailed Description:
This is a nonrandomized, open-label, multicenter study to investigate the HIV antiviral response in CSF when vicriviroc is added for 2 weeks to the subject's failing antiretroviral background regimen. The primary efficacy endpoint of this study is the mean change in log10 CSF HIV RNA from baseline at Week 2. The secondary efficacy endpoint is the proportion of subjects achieving CSF HIV RNA <50 copies/mL at Week 2. At Week 2, the subject's background regimen will be optimized and vicriviroc continued up to Week 24. After completing Week 24 of the study, subjects will be offered the option to continue on open-label VCV 30 mg once daily, if appropriate, until commercially available or until the sponsor terminates the clinical development of VCV. Subjects who discontinue vicriviroc for any reason will be requested to participate in long-term follow up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vicriviroc on HIV RNA Levels in Cerebrospinal Fluid
Study Start Date : March 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: VCV + Failing HAART
Vicriviroc plus failing highly-active antiretroviral therapy
Drug: Vicriviroc
One tablet of vicriviroc maleate 30 mg once daily for 24 weeks (added to the subject's failing antiretroviral background regimen for 2 weeks, and then administered with optimized background therapy).
Other Name: Vicriviroc maleate, SCH-D, SCH 417690, VCV

Primary Outcome Measures :
  1. Change in HIV RNA levels in CSF [ Time Frame: Pretreatment and Week 2 visits ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving CSF HIV RNA <50 copies/mL [ Time Frame: Week 2 ]

Information from the National Library of Medicine

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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:

  • A subject must be at least 18 years of age at the time of study entry, of either sex, and of any race.
  • A subject must be infected with HIV-1 virus, as documented by a positive assay for HIV-1 RNA in plasma, prior to Screening.
  • A subject's HIV isolate must be solely CCR5-tropic at Screening (ie, a subject must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates).
  • Subjects must be failing their current antiretroviral regimen with plasma HIV RNA >=1000 copies/mL at the time of screening. (Note: The failing background regimen must contain a ritonavir-boosted PI, and may not include an NNRTI.)
  • A subject must be willing to undergo study procedures including lumbar punctures, and to adhere to the chosen antiretroviral regimen.
  • A subject must have a pretreatment CSF HIV RNA of >=200 copies/mL.

Exclusion Criteria:

  • A subject must not be taking medication for seizure control or have any condition that, in the judgment of the investigator, is likely to increase the risk of seizures.
  • A subject must not have a prior history of malignancy (with the exception of surgically resected basal cell carcinoma with clear margins or Kaposi's sarcoma without visceral or mucosal involvement that resolved without systemic anticancer treatment).
  • A subject must not have a contraindication to lumbar puncture (eg, bleeding diathesis or use of anticoagulants).

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00632073     History of Changes
Other Study ID Numbers: P05241
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Merck Sharp & Dohme Corp.:
HIV Infections
Acquired Immunodeficiency Syndrome
treatment experienced

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
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action