Protocol Issues


Date Issue Decision that hast been taken (red: Propositions, not decided yet)
30.5.07 DEXA-Scan

All participants agreed that DEXA should not be dropped immediately · PV will make an evaluation of Budget cost · BH will help to get additional funding for the DEXA Project from the HIV research foundation · We have 6-8 weeks time to run the DEXA

30.5.07 HIV-RNA Confirmatory HIV-RNA (in the central lab) will be done after each HIV-RNA elevation above 100cp/ml. This is not equivalent to failure but will allow rapid detection of increases.
30.5.07 NP test NP has to be done at BL. Synove Daneel will be responsible for training of the sites
30.5.07 ScreenLog A screening log should be used to document all the patients that have been asked but rejected to participate in the study. The excell file can be downloaded here


Special request can be done by e-mail to Franziska Zenger: She will forward the request to BH and PV for a final decision. If SG or GE is involved, Milos Opravil would be the second reviewer.
21.06.2007 DEXA- Scan DEXA- Scan will be done at BL, w48 and decision will be made after w48 if w96 will also be done; this will be mentioned in the protocol amendment
07.11.2007 Continous arm: Medication change After medication change in the continous arm during the first year, swith to LPV/r will not be possible, therefore terminate this patients at week 48
 14.03.2008 Termination visit Failing patiens should receive a CSF at the second (confirmatory) visit including blood collection and drug levels
 08.05.2008  Activation parameters

Additional lab (PBMC and plasma) storage will be taken at week 6 and 54 and sent to Geneva