Status:

COMPLETED

Cerebrospinal Fluid (CSF) Raltegravir Substudy

Lead Sponsor:

University of California, San Diego

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Conditions:

HIV Infections

Eligibility:

All Genders

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT00718029

Start Date

July 1 2008

End Date

February 1 2011

Last Update

August 13 2019

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