drugset / Trial / NCT01195467

Atripla to Raltegravir Switch Study for CNS Toxicity

NCT01195467

Phase 3 Completed 40 enrolled St Stephens Aids Trust
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to investigate the benefits of switching away from efavirenz (part of the combination pill, Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators will investigate the effect of switching to Truvada (a combination pill of tenofovir and emtricitabine, the other two components of Atripla) plus raltegravir. Raltegravir is a licensed drug for HIV treatment which showed side effects were fewer in number when compared to efavirenz in 2 other clinical studies, where patients were starting HIV treatment for the first time. This study will also investigate the safety (in terms of other side effects and the routine blood tests which the investigators ordinarily use to monitor your treatment) and monitor effectiveness, your viral load and CD4 counts, when you switch treatment from Atripla® to Truvada/raltegravir.

Timeline

Start
2010-10
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Raltegravir Other / unclassified
Subject Tenofovir Small molecule
Subject emtricitabine Other / unclassified