NCT00718029

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

July 16, 2008

Last Update Submit

August 8, 2019

Conditions

HIV Infections

Keywords

Human Immunodeficiency VirusCerebrospinal FluidRaltegravirDrug Concentrations

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

CSF, PBMC, plasma

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Scott L Letendre, MD

    University of California, San Diego AntiViral Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 18, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

February 1, 2011

Last Updated

August 13, 2019

Record last verified: 2019-08