Evaluation of the effect of an antiretroviral drug in patients infected with HTLV-1.

INTERVENTION: One hundred participants will be recruited, divided into two groups. Group 1 (use of DTV, 50 mg/day) 50 individuals (35 HAM/TSP+15 asymptomatic carriers). Group 2 (use of VIT C 500 mg/day) 50 individuals (35 HAM/TSP+15 asymptomatic carriers). Outcome measures from the Exposure (DTG) and control (Vitamin C) groups will be evaluated at baseline and at regular intervals. Primary outcomes will be evaluated at week 48 (1 year). Assessments will also be performed at 4, 12, 24, 48, and 96 weeks (2 years) to better assess immediate effects and their potential durability. D27.505.519.389.675.850 CONDITION: Human T‐lymphotropic virus 1 B04 PRIMARY OUTCOME: Improvement in timed gait assessed by the 10‐meter walk test (TC10), from a decrease in TC10 of 21.5% measured from the start of the intervention and throughout the follow‐up (0‐96 weeks). SECONDARY OUTCOME: Changes in body composition verified by RJL Systems bioelectrical impedance analysis (BIA) measured at baseline time of intervention, after 24, 48, and 96 weeks. Variations in health‐related quality of life (HRQoL) using the Medical Outcomes Study Short‐Form 36 Item Survey (SF‐36, version 2) instrument from baseline and after 24, 48, and 96 weeks. Changes in additional functional/clinical measures, urinary frequency, strength, sensitivity disorders and pain intensity, through the application of a battery of physical‐functional tests [10‐meter walking test (10MWT); Modified Ashworth Scale; Kendall Scale; American Spinal Injury Association (ASIA) Impairment Scale; Analogic visual scale; Manual dynamometry] measured from baseline and throughout follow‐up (4, 12, 24, 48, and 96 weeks). Changes in measurements of pro‐inflammatory immune markers verified by multiplex biometric immunoassay containing microspheres conjugated with monoclonal antibody to protein targets revealed by fluorescent staining for cytokine quantification, according to instructions from time zero, and after 4, 24, 48 and 96 weeks. Changes in the frequency of activated T cells in HTLV‐1 carriers, verified by four‐color flow cytometry at time zero, and after 4, 24, 48, and 96 weeks. INCLUSION CRITERIA: Volunteers aged over 18 years, of both genders, have been diagnosed (by Western blot or PCR) with HTLV‐1; not present neurological or cognitive deficits that interfere in the performance of any of the proposed activities.