drugset / Trial / NCT00792324

Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125

NCT00792324

Phase 3 Completed 24 enrolled St Stephens Aids Trust
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

EvaluationDrugModalityDoseRoute
Comparator Efavirenz Other / unclassified 600 mg
Comparator Etravirine Small molecule 400 mg