BIT Science Discussion, page-25

Unfortunately Daviste is scare mongering and full of it. Apparently he doesn’t even know how to read his own links....

There are two primary outcomes, and one secondary. He can’t read..... primary outcome 1 is evaluate antiviral activity (see below). I have followed BIT for a long time. He doesn’t know what he is talking about, so be careful.

He has also been on the end of some full scale failures, so his track record is patchy at best.

He also seems to not understand the differences between, Phase 1, phase 2a, phase 2b and phase 3.

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Primary outcome [1]
Evaluate the antiviral activity of BIT225 (QD) administered for 12 consecutive weeks in combination with cART: Atripla in HIV-1 infected patients who are treatment naive to antiretroviral treatment.
Timepoint [1]
HIV-1 plasma viral load will be determined by Roche COBAS TaqMan HIV-1 (Roche Diagnostics). Blood samples for HIV-1 RNA assays will be collected at: Screening; Day 1 (BIT225 200 mg cohort only), 2, 4, 7, 10, 14, 17, 21, 24, Weeks 4, 6, 9, 12, and in follow-up in Weeks 13, 14, 16 and 24.
Plasma samples for a SCA to quantitate low level HIV-1 RNA will be collected from the BIT225 200 mg cohort only at: Screening; Day 7, 10, 14, 17, 21, Weeks 4, 6, 9, 12, and in follow-up in Weeks 16 and 24.
Primary outcome [2]
Determine the safety and tolerability of BIT225 QD administered for 12 consecutive weeks in HIV-1 infected patients on cART: Atripla, that are antiretroviral treatment naive.
Safety and tolerability will be assessed by comparison to placebo of treatment emergent untoward medical changes, e.g. changes in clinical laboratory assessments, vital signs, and ECG measures.
Timepoint [2]
Medical changes and vital signs will be evaulated at Screening, Day 1, 2, 4, 7, 10, 14, 17, 21, 24, and Weeks 4, 6, 9, 12 and follow-up Weeks 13, 14, 16 and 24.
Clinical laboratory measures will be evaluated at Screening, on Day 1 (BIT225 200 mg) or Day 2 (BIT225 100 mg), and Weeks 2, 4, 6, 9, 12 and follow-up Weeks, 16 and 24.
ECG measurements will be evaluated at Screening, Days 1, 2, 4, 7 and 10, and Weeks 2, 3, 4,