The trialhas been completed and unblinded and have been advised...

The trialhas been completed and unblinded and have been advised they are exploring ortesting for quite a range of bio markers , which has been very difficult to do, could you assist in explaining what process is or entail , and what biomarkers they may be .

You're right, testing for biomarkers in HIVpatients with undetectable viral loads is a complex task. Here's a breakdown ofthe process and potential biomarkers Biotron might be exploring:

The Biomarker Exploration Process:

1. Hypothesis-driven selection: Biotron likely has a hypothesis about how BIT225 might work against HIV. Based on this hypothesis, they would select specific biomarkers that might be affected by the drug.
2. Literature review and existing data analysis: Researchers would review scientific literature to identify existing knowledge about potential biomarkers for HIV cure or eradication strategies. They might also analyze data from previous trials of BIT225 or other drugs targeting HIV.
3. Assay development and validation: Once potential biomarkers are identified, researchers would need to develop or use existing assays (tests) to measure these markers in patient samples. These assays need to be validated to ensure they are accurate, reliable, and sensitive enough to detect small changes.
4. Sample collection and analysis: Blood or tissue samples are collected from study participants at different time points during the trial. These samples are then analyzed for the presence and quantity of the chosen biomarkers.
5. Data analysis and interpretation: Statistical methods are used to analyze the data and see if there are any significant changes in biomarker levels between patients who received BIT225 and those who received a placebo.

Potential Biomarkers for HIV Cure/Eradication:

Here are some potential biomarker categoriesBiotron might be exploring:

• Viral Reservoir Markers: These markers directly or indirectly assess the size and activity of the HIV reservoir. Examples include:
  • Total HIV DNA: Measures the total amount of HIV genetic material present in cells.
  • Integrated HIV DNA: Measures the amount of HIV DNA that has become integrated into the host cell genome.
  • Replication-competent HIV: Attempts to measure the number of infected cells that can actively produce new virus particles.
• Immune Response Markers: These markers assess the immune system's ability to control HIV infection. Examples include:
  • HIV-specific T cells: Measures the number and function of immune cells that target HIV.
  • Viral load rebound time in ATI: Measures the time it takes for detectable HIV viral load to reappear after stopping ART (Analytical Treatment Interruption).
  • Inflammatory markers: Measures levels of molecules associated with chronic immune activation, which can be a target for HIV eradication strategies.
• Drug Target Engagement Markers: These markers assess whether BIT225 is interacting with its intended target in the body. This could help confirm if the drug is reaching its target and potentially impacting HIV.