drugset / Trial / NCT01293123
Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2013-06
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |