drugset / Trial / NCT00792324
Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125
RandomizedSingle-groupTriple-blindTreatment
Summary
The purpose of the study is to examine the effect of switching from an antiretroviral combination that includes efavirenz (Susitiva®), in individuals experiencing efavirenz-related side effects, and replacing this with an investigational HIV medication called Etravirine (TMC125). The study will primarily investigate the effect of change in medication on your viral load (the levels of the HIV virus in your blood), on immunological parameters (CD4 count), on other safety parameters (such as cholesterol) your side effects and also on your quality of life.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-08
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | — |
| Comparator | Etravirine | Small molecule | 400 mg | — |