Objective
To collect information which helps to define the best use of Fortovase®
(FTV) based on virus genotype, including:
- how often patients are not eligible to receive FTV due to resistance
- clinical outcome of FTV when used optimally according to genotype
- whether failure is associated with resistance to FTV or to RT inhibitors
- best options for switching drug(s) if a patient develops resistance to FTV
- clinical outcome of switch options after using FTV
Concept
- Any prior therapy is allowed, and there are no restrictions on how FTV is prescribed.
- Data are collected: at entry; at 24 and 48 wks.
- If still on same therapy; in the event of failure; then 12 wks. after switch.
- Roche affiliates nominate physicians and labs according to their expertise and
resources.
- Roche affiliates can choose the type of gene sequencing technology.
- Physican signs up to the programme and receives RetroGram software.
Roche Pharma affiliates provide
- Replacement genotype and viral load (state of the art, ultrasensitive) assays
- Any investigator fees
Roche HQ provides
- RetroGram decision support software
- Overall program coordination; data management e.g. by Virology Networks
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