No. Have a look at what the two primary end points were for the BIT-009 trial.
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372075
Outcomes
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, 6, 9, 12 and follow-up Weeks 13, 14, 16 and 24.
Secondary outcome [1]
Evauate if 12 weeks of BIT225 treatment in addition to cART: Atripla will impact levels of sCD163, a primary biomarker of monocyte immune activation.
Timepoint [1]
Blood samples for detection of immune marker sCD163 will be collected from all participants in the BIT225 200mg/placebo cohort at Screening, and then at Day 7, 10, 14, 17, 21, and at Weeks 4, 6, 9 12 and follow-up Weeks 16, and 24 and will be determined by ELISA.
Secondary outcome [2]
To evaluate the pharmacokinetics (PK) of 100 mg BIT225 QD administered for 12 consecutive weeks in combination with cART:Atripla 'Registered Trademark' in patients infected with HIV-1.
Timepoint [2]
A sub-group of 9 participants in the BIT225 100mg cohort will participate in the intensive PK sub-study.
PK samples will be collected at pre-Atripla dose on Day 1 and Week 12, and at 0.5 hour post Atripla dose as well as 0.5, 1, 2.5, 4, 6, 8, 12 and 24 hours after BIT225 dosing on both days, as well as a 48 and 96 hour sample after the Week 12 dose. Pharmacokinetic parameters assessed will include; Cmax, Tmax, AUC and T1/2.
PK samples will also be collected from all participants pre-dose on Days 4, 10 and 21, Weeks 4, 9, and 12. These samples will be used to determine the trough plasma concentration of BIT225, as well as tracking compliance to dosing.
The concentration of BIT225 in the plasma will be measured using a validated liquid chromatography tandem mass spectrometry method.
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The two primary outcomes were plasma viral load reduction (blood) and safety. BIT225 failed the Primary 1 outcome and we assume passed Primary 2 outcome (we don't really know as details on this have not been reported). The data that will be presented at the end of November will be on the Secondary 1 outcome based on the title of MM's presentation.
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