Cerebrospinal Fluid (CSF) Raltegravir Substudy
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00718029
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method