HTLV-I-Associated Myelopathy
Conditions
Keywords
HTLV, HAM/TSP, VALPROIC ACID, PROVIRAL LOAD
Brief summary
Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.
Interventions
DRUGValproic Acid
Valproic acid by oral route (20mg/Kg/day) during one year.
Sponsors
University Hospital Pierre Zobda-Quitman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* HAM/TSP patients diagnosed on WHO criteria * Obtained informed consent.
Exclusion criteria
* Patients with hepatic or nephrologic disease * Valproic Acid allergy * Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Neurological outcome. | one year |
Outcome results
None listed