HIV Infections Clinical Trial
Official title:
A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects
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)
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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