Cerebrospinal Fluid (CSF) Raltegravir Substudy

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

MK: Raltegravir Concentrations in Cerebrospinal Fluid

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2011
First posted: Jul 18, 2008
Registry last updated: Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed