Cerebrospinal Fluid (CSF) Raltegravir Substudy

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: NCT00718029
Recruitment Status : Unknown
Verified July 2008 by University of California, San Diego.
Recruitment status was:  Enrolling by invitation
First Posted : July 18, 2008
Last Update Posted : July 24, 2008
Merck Sharp & Dohme Corp.
Information provided by:
University of California, San Diego

Brief Summary:

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 or disease
HIV Infections

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MK: Raltegravir Concentrations in Cerebrospinal Fluid
Study Start Date : July 2008
Estimated Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

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

Biospecimen Retention:   Samples With DNA
CSF, PBMC, plasma

Information from the National Library of Medicine

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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.

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.

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 identifier (NCT number): NCT00718029

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

Responsible Party: Scott Letendre, MD, UCSD AVRC Identifier: NCT00718029     History of Changes
Other Study ID Numbers: MK: 33132
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2008

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