drugset / Trial / NCT01694017

Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy

NCT01694017

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare clinical, economical and quality of life (QOL) outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen. This study will be an unblinded randomized trial. The first step will be empirical data collection for one year for calculating the incremental cost effectiveness ratio (ICER). The second step will be to perform a simulation model for calculating long term ICER.

Timeline

Start
2012-11
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Efavirenz Other / unclassified 600 mg
Comparator Lamivudine Other / unclassified 150 mg
Comparator Nevirapine Small molecule 200 mg
Comparator Tenofovir Small molecule 300 mg
Comparator Zidovudine Small molecule 300 mg
Comparator emtricitabine Other / unclassified 200 mg