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Effect of Vicriviroc on HIV Ribonucleic Acid (RNA) Levels in Cerebrospinal Fluid (Study P05241 AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00632073
First received: January 24, 2008
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Vicriviroc
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Vicriviroc on HIV RNA Levels in Cerebrospinal Fluid

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in HIV RNA levels in CSF [ Time Frame: Pretreatment and Week 2 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving CSF HIV RNA <50 copies/mL [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00632073     History of Changes
Other Study ID Numbers: P05241
Study First Received: January 24, 2008
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
HIV Infections
Acquired Immunodeficiency Syndrome
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013