Overview

The First Failure Study

Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 4
Details
Lead Sponsor:
Imperial College London
Treatments:
Darunavir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Etravirine
Ritonavir