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

NCT02655471 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-05-22

No results posted yet for this study

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.

Conditions

  • HTLV-I Infections
  • Tropical Spastic Paraparesis

Interventions

DRUG

"Raltegravir" and "Zidovudine"

Through measure of pro-viral load and clinical score, we evaluate about safety and efficacy of combination of Raltegravir 400 mg BID and zidovudine 300 mg BID in patients with recent onset of Tropical Spastic paraparesis due HTLV-1 during 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Eduardo Gotuzzo, MD · Instituto de Medicina Tropical Alexander von Humboldt

  • Fernando Mejía, MD · Instituto de Medicina Tropical Alexander von Humboldt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-03-15
Completion
2019-03-15
FDA Drug
Yes

Countries

  • Peru

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655471 on ClinicalTrials.gov