Cerebrospinal Fluid (CSF) Raltegravir Substudy

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00718029
First received: July 16, 2008
Last updated: July 23, 2008
Last verified: July 2008

July 16, 2008
July 23, 2008
July 2008
July 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00718029 on ClinicalTrials.gov Archive Site
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Cerebrospinal Fluid (CSF) Raltegravir Substudy
MK: Raltegravir Concentrations in Cerebrospinal Fluid

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

CSF, PBMC, plasma

Non-Probability Sample

Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15
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July 2009   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00718029
MK: 33132
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Scott Letendre, MD, UCSD AVRC
University of California, San Diego
Merck Sharp & Dohme Corp.
Principal Investigator: Scott L Letendre, MD University of California, San Diego AntiViral Research Center
University of California, San Diego
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP