drugset / Trial / NCT00765154

NNRTI/PI Toxicity Switch to Darunavir Study

NCT00765154

Phase 4 Terminated 12 enrolled St Stephens Aids Trust
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to examine the effects of switching from antiretroviral combinations that includes efavirenz (Sustiva®), lopinavir/ritonavir (Kaletra®) or atazanavir/ritonavir (Reyataz®/Norvir®) in individuals experiencing side effects from one of these agents, and replacing these with a new HIV medication called Darunavir also given with ritonavir (Norvir®). The study will primarily investigate the effect of change in medication on the subjects viral load (the levels of the HIV virus in the blood), on immunological parameters (CD4 count) and on other safety parameters (such as cholesterol) and also quality of life.

Timeline

Start
2008-10
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darunavir Small molecule 800 mg Oral
Comparator Ritonavir Other / unclassified 100 mg Oral