The First Failure Study (FAST)
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|ClinicalTrials.gov Identifier: NCT01118871|
Recruitment Status : Terminated
First Posted : May 7, 2010
Last Update Posted : March 24, 2015
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)
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infections||Drug: Darunavir, Ritonavir, Truvada Drug: Darunavir, Ritonavir and Etravirine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|Active Comparator: Standard of care||
Drug: Darunavir, Ritonavir, Truvada
Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
|Experimental: NRTI sparing arm||
Drug: Darunavir, Ritonavir and Etravirine
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
- Mean change from baseline in peripheral and central adipose tissue [ Time Frame: week 48 and 96 ]As measured by DEXA, between treatment arms.
- Percentage of patients <50 copies HIV-1 RNA/mL [ Time Frame: 96 weeks ]At all study points to weeks 48 and 96 between treatment arms.
- Mean change from baseline of absolute CD4+ T cell count [ Time Frame: 96 weeks ]between treatment arms
- Time to change in randomly assigned therapy [ Time Frame: 96 weeks ]between treatment arms
- Mean change from baseline Lipodystrophy Case Definition score [ Time Frame: 96 weeks ]Between treatment arms
- Mean change from baseline in fasting lipid and glycaemia parameters [ Time Frame: 96 weeks ]between treatment arms
- Mean change from baseline in cardiac and bone biomarker levels [ Time Frame: Week 96 ]between treatment arms
- • Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs [ Time Frame: 96 week s ]Between the treatment arms
- Patterns of genotypic HIV resistance associated with virological treatment failure [ Time Frame: 96 weeks ]Across the treatment arms
- Describe aspects of immune reconstitution disease (IRD) [ Time Frame: 96 weeks ]Across the treatment arms
- Comparison of quality of life and results of adherence questionnaires [ Time Frame: 96 weeks ]Between the treatment arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118871
|St. Mary's Hospital|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Alan Winston, MB ChB||Imperial College London|