A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects
Overview
- Phase
- Phase 4
- Intervention
- Darunavir, Ritonavir, Truvada
- Conditions
- HIV
- Sponsor
- Imperial College London
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Mean change from baseline in peripheral and central adipose tissue
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief 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)
Investigators
Eligibility 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 \< 400 copies/mL at screening)
Exclusion Criteria
- •current alcohol abuse or drug dependence
- •pregnancy
- •active opportunistic infection or significant co-morbidities
- •current prohibited concomitant medication
- •a likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing
Arms & Interventions
Standard of care
Intervention: Darunavir, Ritonavir, Truvada
NRTI sparing arm
Intervention: Darunavir, Ritonavir and Etravirine
Outcomes
Primary Outcomes
Mean change from baseline in peripheral and central adipose tissue
Time Frame: week 48 and 96
As measured by DEXA, between treatment arms.
Secondary Outcomes
- Percentage of patients <50 copies HIV-1 RNA/mL(96 weeks)
- Mean change from baseline Lipodystrophy Case Definition score(96 weeks)
- Describe aspects of immune reconstitution disease (IRD)(96 weeks)
- Comparison of quality of life and results of adherence questionnaires(96 weeks)
- Time to change in randomly assigned therapy(96 weeks)
- • Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs(96 week s)
- Mean change from baseline of absolute CD4+ T cell count(96 weeks)
- Mean change from baseline in fasting lipid and glycaemia parameters(96 weeks)
- Patterns of genotypic HIV resistance associated with virological treatment failure(96 weeks)
- Mean change from baseline in cardiac and bone biomarker levels(Week 96)