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 |
| 21.6.07 |
Exemption |
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 |
