- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00632073
Effect of Vicriviroc on HIV Ribonucleic Acid (RNA) Levels in Cerebrospinal Fluid (Study P05241)
February 20, 2015 updated by: Merck Sharp & Dohme LLC
Effect of Vicriviroc on HIV RNA Levels in Cerebrospinal Fluid
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).
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VCV + Failing HAART
Vicriviroc plus failing highly-active antiretroviral therapy
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HIV RNA levels in CSF
Time Frame: Pretreatment and Week 2 visits
|
Pretreatment and Week 2 visits
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects achieving CSF HIV RNA <50 copies/mL
Time Frame: Week 2
|
Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
March 7, 2008
First Posted (Estimate)
March 10, 2008
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 20, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Maleic acid
Other Study ID Numbers
- P05241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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