HIV
Conditions
Interventions
Trade Name: Intelence
Product Name: Etravirine
Pharmaceutical Form: Tablet
Trade Name: Prezista
Product Name: Darunavir
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • HIV-1 infected males or females • over 18 years of age • signed informed consent • currently receiving a stable antiretroviral regimen comprising of: - two or more licensed NRTIs - one licensed NNRTI or boosted protease inhibitor • no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing • failure of current antiretroviral regimen due to: - toxicity, intolerance or virological failure if receiving an NNRTI containing regimen at screening - toxicity or intolerance if receiving a boosted-protease inhibitor regimen at screening (with plasma HIV RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • current alcohol abuse or drug dependence • pregnancy • active opportunistic infection or significant co-morbidities • current prohibited concomitant medication (as listed in section 4.1.4) • a likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences between two such treatment approaches include differences in body fat distribution, in blood fat levels, in adherence and in neurocognitive function. The primary objective is to measure the changes from baseline in peripheral and central body fat, as measured by DEXA scan at weeks 48 and 96 between the treatment arms. ; Secondary Objective: •Percentage of patients <50 copies HIV-1 RNA/mL at all study points to weeks 48 and 96 between treatment arms. •Change from baseline in CD4+ T cell count at weeks 48 and 96 between treatment arms. •Time to this change in randomly assigned therapy between treatment arms. •Change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between treatment arms •Change from baseline in fasting blood fats at weeks 48 and 96 between treatment arms. •Change from baseline in cardiac and bone biomarker levels. •Comparison of total number of patients with any serious adverse events (SAEs), and the rates of SAEs, between treatment arms. •Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms. •Describe aspects of immune reconstitution disease (IRD). •Comparison of quality of life and results of adherence questionnaires between treatment arms. •Changes in neurocognitive function between treatment arms •To describe darunavir an ; Primary end point(s): Mean change from baseline in peripheral and central adipose tissue, as measured by DEXA, at weeks 48 and 96 between treatment arms. Less limb fat loss as measured by DEXA scans over 48 weeks will be observed in a nucleoside sparing a | — |
Countries
United Kingdom
Outcome results
None listed