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Cerebrospinal Fluid (CSF) Raltegravir Substudy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by University of California, San Diego.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00718029
First Posted: July 18, 2008
Last Update Posted: July 24, 2008
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of California, San Diego
  Purpose

The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid.

The hypotheses are:

  • Raltegravir concentrations in CSF will be measurable
  • Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios.
  • Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MK: Raltegravir Concentrations in Cerebrospinal Fluid

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Biospecimen Retention:   Samples With DNA
CSF, PBMC, plasma

Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.
Criteria

Inclusion Criteria:

  • Enrollment in a raltegravir parent protocol at UCSD.
  • Willing to undergo lumbar puncture.
  • Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure.

Exclusion Criteria:

  • Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets<50,000/µL), hemophilia, or use of anticoagulant medication.
  • Psychiatric disease that would interfere with study participation, in the opinion of the investigator.
  • No major opportunistic infections within 30 days.
  • Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718029


Sponsors and Collaborators
University of California, San Diego
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Scott L Letendre, MD University of California, San Diego AntiViral Research Center
  More Information

Responsible Party: Scott Letendre, MD, UCSD AVRC
ClinicalTrials.gov Identifier: NCT00718029     History of Changes
Other Study ID Numbers: MK: 33132
First Submitted: July 16, 2008
First Posted: July 18, 2008
Last Update Posted: July 24, 2008
Last Verified: July 2008

Keywords provided by University of California, San Diego:
Human Immunodeficiency Virus
Cerebrospinal Fluid
Raltegravir
Drug Concentrations

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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