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Cerebrospinal Fluid (CSF) Raltegravir Substudy

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Merck
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00718029
First received: July 16, 2008
Last updated: July 23, 2008
Last verified: July 2008
History of Changes
  Purpose

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.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MK: Raltegravir Concentrations in Cerebrospinal Fluid

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Biospecimen Retention:   Samples With DNA

CSF, PBMC, plasma


Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718029

Sponsors and Collaborators
University of California, San Diego
Merck
Investigators
Principal Investigator: Scott L Letendre, MD University of California, San Diego AntiViral Research Center
  More Information

No publications provided

Responsible Party: Scott Letendre, MD, UCSD AVRC
ClinicalTrials.gov Identifier: NCT00718029     History of Changes
Other Study ID Numbers: MK: 33132
Study First Received: July 16, 2008
Last Updated: July 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Human Immunodeficiency Virus
Cerebrospinal Fluid
Raltegravir
Drug Concentrations

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013