$10 Billion Deal, page-166

From trial
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372075

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.

This study aims to demonstrate if the addition of BIT225 to cART will result in improved reductions in plasma viral load, determine the importance of the myeloid reservoir in viral persistence and the effectiveness of BIT225 in inhibiting viral release from these cell types.


"The data shows that there are significant immunological benefits in patients receiving antiretroviral drugs with 200 mg BIT225 compared to antiretroviral drugs plus placebo."

We can speculate plasma viral load has improved in the combination of BIT255 and cART. The importance of viral persistence is not yet determined in this trial. These include an immune system ages more quickly, and there are other problems such as HIV-associated neurocognitive disorder (also known as AIDS-related dementia) .

It will be interesting to compare viral loads achieved in the BIT trial compared to phase 3 results from CytoDyn Inc

https://seekingalpha.com/article/41...te-stage-hiv-combo-results-using-prominus-140

"It was shown that 81% of the patients that completed the 25-week CD02 pivotal trial of Pro-140 in combination with highly active antiretroviral therapy (HAART) were able to achieve viral load suppression with plasma HIV-1 RNA viral load < 50 copies/mL. That's a huge percentage of patients that achieved viral load suppression. But why exactly is that many patients achieving such a huge viral load suppression a good thing. That's because if you take a look at all other HIV therapies the main goal is to attempt to get viral load levels below 50 copies/mL, which at that point has a transmission rate of about zero. "