MK: Raltegravir Concentrations in Cerebrospinal Fluid

University of California, San Diego0 个研究点目标入组 4 人开始时间: 2008年7月最近更新: 2019年8月13日

适应症

试验速览

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.

•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.

•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.

发起方

申办方类型

Other

责任方

Sponsor