drugset / Trial / NCT00529243

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

NCT00529243

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, \< 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen. Hypothesis: HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.

Timeline

Start
2007-09
Primary completion
2008-07
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Raltegravir Other / unclassified 400 mg