Cerebrospinal Fluid (CSF) Raltegravir Substudy

University of California, San Diego4 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infections

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.