HCQ-01 - Hydroxychloroquine study

[newt]

"Evaluation of the efficacy of hydroxychloroquine in decreasing immune activation and viral replication in asymptomatic Human Immunodeficiency Virus (HIV)-infected patients" ie some of us folk.

A phase II, multi-centre, randomised, double-blind, placebo-controlled clinical trial

Details of this study were requested in this thread:
http://forums.poz.com/index.php?topic=23019.0

The ISRCTN register entry for this trial is: ISRCTN30019040

This study aims to determine whether hydroxychloroquine decreases immune activation in HIV, measured by least a 25% reduction in CD8 T-cell activation after 48 weeks of treatment. The study also intends to examine the effects of hydroxychloroquine on viral load and CD4 T-cell count at week 48, and to assess safety of hydroxychloroquine in this patient population.

The primary outcome measure is change in CD8 T-cell activation at week 48 compared to baseline in the two study groups (as shown by a percentage of the cells expressing CD38+ and HLA-DR+).

Secondary efficacy outcome measures, considered as change from baseline to week 48:

1. CD4 T-cell activation (as shown by the percentage of the cells expressing CD38+ and HLA-DR+)
2. Absolute CD4 T-cell count
3. IL-6 concentration
4. HIV viral load (expressed in log^10 copies/ml)

plus a bunch on safety and tolerability.

Community representation arranged via the UK-CAB.

This is a Medical Research Council Clinical Trials Unit study and will recruit across the UK.

- matt

[leit]

Thank you very much, "newt" and... let's hope!

Only a doubt: hydroxychloroquine "inhibits the posttranslational modification of glycoprotein 120 (gp 120) in T cells and monocytes", so it itself inhibits HIV. Don't you think this could be a confounding factor?

Another question, please: the above linked abstract talks about newly and chronically infected T and monocytic cells. Are those "newly" and "chronically" synonymous with something else?

Thanks again!