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

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Peruana Cayetano Heredia
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium; Zidovudine

Criteria

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.