MedTrace Logo

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

NCT01293123 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-10-31

Study results available
· View outcomes & findings →

Summary

The primary aim of this study is to determine the effects of the HIV integrase inhibitor, raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF before and after initiation of either raltegravir or another antiretroviral, efavirenz, each in combination with two other antiretrovirals. Assessments will include HIV RNA levels (viral load), neuropsychological testing, mood assessments, and quality of life assessments.

Conditions

Interventions

DRUG

Raltegravir

raltegravir 400 mg PO twice daily

DRUG

Efavirenz

efavirenz 600 mg PO once daily

Sponsors & Collaborators

Principal Investigators

  • Scott Letendre, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01293123 on ClinicalTrials.gov