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

Early Phase 1

Completed

• Conditions: Tropical Spastic Paraparesis; HTLV-I Infections
• Interventions: Drug: "Raltegravir" and "Zidovudine"

• Registration Number: NCT02655471
• Lead Sponsor: Universidad Peruana Cayetano Heredia

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 Description

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.

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-14
• Study Start: 2017-07-01
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HTLV-1 plus Tropical Spastic paraparesis	"Raltegravir" and "Zidovudine"	Patients with recent onset of Tropical Spastic paraparesis due HTLV-1 will receive combination of "Raltegravir" and "Zidovudine" during 48 weeks

Primary Outcome Measures

Name	Time	Method
Measure of proviral load	48 weeks	Evaluate the effect of raltegravir on proviral load , measured as copies/1000 PBMC, in patients with myelopathy of recent onset associated to HTLV-1 at 48 weeks.

Secondary Outcome Measures

Name	Time	Method
Measure of Disability Scale	48 weeks	Evaluate the effect of raltegravir on Kurtzke Expanded Disability Status Scale in patients with myelopathy of recent onset associated to HTLV-1 at 48 weeks.

Trial Locations

Locations (1)

Instituto de Medicina Tropical Alexander von Humboldt; 🇵🇪 Lima, Peru