drugset / Trial / NCT01118871

The First Failure Study

NCT01118871

Phase 4 Terminated 3 enrolled Imperial College London
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to look at two different antiretroviral treatment options in individuals who are about to commence their second antiretroviral treatment. This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences include: differences in body fat distribution, in lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking to show differences in body fat distribution between the two study treatment arms. Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive function will also be assessed. There is also a lumbar puncture sub study participants can also take part in. The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years) plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64, 80 and 96)

Timeline

Start
2010-05
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Etravirine Small molecule 400 mg
Comparator Tenofovir Small molecule 245 mg
Comparator emtricitabine Other / unclassified 200 mg
Comparator Darunavir Small molecule 800 mg
Comparator Ritonavir Other / unclassified 100 mg