drugset / Trial / NCT01335620

The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

NCT01335620

Phase 4 Completed 19 enrolled Imperial College London
NaSingle-groupOpen-labelTreatment

Summary

This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study. Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to: * tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus * raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

Timeline

Start
2011-04
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Raltegravir Other / unclassified 400 mg
Background Tenofovir Small molecule 245 mg
Background emtricitabine Other / unclassified 200 mg