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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
St. Mary's Hospital
London, United Kingdom
Mean change from baseline in peripheral and central adipose tissue
As measured by DEXA, between treatment arms.
Time frame: week 48 and 96
Percentage of patients <50 copies HIV-1 RNA/mL
At all study points to weeks 48 and 96 between treatment arms.
Time frame: 96 weeks
Mean change from baseline of absolute CD4+ T cell count
between treatment arms
Time frame: 96 weeks
Time to change in randomly assigned therapy
between treatment arms
Time frame: 96 weeks
Mean change from baseline Lipodystrophy Case Definition score
Between treatment arms
Time frame: 96 weeks
Mean change from baseline in fasting lipid and glycaemia parameters
between treatment arms
Time frame: 96 weeks
Mean change from baseline in cardiac and bone biomarker levels
between treatment arms
Time frame: Week 96
• Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Between the treatment arms
Time frame: 96 week s
Patterns of genotypic HIV resistance associated with virological treatment failure
Across the treatment arms
Time frame: 96 weeks
Describe aspects of immune reconstitution disease (IRD)
Across the treatment arms
Time frame: 96 weeks
Comparison of quality of life and results of adherence questionnaires
Between the treatment arms
Time frame: 96 weeks
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