Cerebrospinal Fluid (CSF) Raltegravir Substudy

MK: Raltegravir Concentrations in Cerebrospinal Fluid

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00718029

Enrollment

Registered

2008-07-18

Start date

2008-07-31

Completion date

2011-02-28

Last updated

2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Human Immunodeficiency Virus, Cerebrospinal Fluid, Raltegravir, Drug Concentrations

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Outcome results