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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Raltegravir in Patients With Myelopathy/Tropical Spastic Paraparesis Associated With Infection by Human T-Lymphotropic Virus 1 (HTLV-1). Pilot Study

Brief 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.

Detailed Summary:

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.

Sponsor: Universidad Peruana Cayetano Heredia

Current Primary Outcome: Measure of proviral load [ Time Frame: 48 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Measure of Disability Scale [ Time Frame: 48 weeks ]

Original Secondary Outcome: Same as current

Information By: Universidad Peruana Cayetano Heredia

Dates:
Date Received: November 16, 2015
Date Started: March 2016
Date Completion: June 2018
Last Updated: January 11, 2016
Last Verified: January 2016