Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection

The study will the investigators develop in The Tropical Medicine Institute Alexander von Humboldt that is a referral center in Peru for diseases associated to Human T-Lymphotropic Virus 1 Infection (HTLV-1). The Institute has a cohort of around 600 patients currently being followed up and around 20 to 25 new patients are admitted every year with this disease.

This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients on the follow-up of 48 weeks.

Inclusion criteria

• human t lymphotrophic virus 1 confirmed
• Tropical Spastic Paraparesis of recent onset (less than 4 years)

Exclusion criteria

• Pregnant or breastfeeding or unwilling to use contraception.
• Treatment with immunosuppressive, immunomodulatory or experimental treatments within the last 6 months of enrolment in the study.
• Patients presenting with medical disorder such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests (>2.5 times upper limit normal (ULN)) and abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte count <500, neutrophil <1.5 or platelet count < 100, or thrombocytopenia < 1.5 low limit normal (LLN), or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the patient.
• Presence of human immunodeficiency virus antibodies.
• Patients with active hepatitis B or/and C with liver function tests >2.5 times ULN
• Exposure to any other investigational drug within 30 days of enrolment in the study.