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

Brief Title

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

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 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 Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Measure of proviral load

Secondary Outcome

 Measure of Disability Scale

Condition

HTLV-I Infections

Intervention

"Raltegravir" and "Zidovudine"

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

July 1, 2017

Completion Date

March 15, 2019

Primary Completion Date

March 15, 2019

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eduardo Gotuzzo, MD, , 

Location Countries

Peru

Location Countries

Peru

Administrative Informations


NCT ID

NCT02655471

Organization ID

65384


Responsible Party

Sponsor

Study Sponsor

Universidad Peruana Cayetano Heredia

Collaborators

 Merck Sharp & Dohme Corp.

Study Sponsor

Eduardo Gotuzzo, MD, Principal Investigator, Instituto de Medicina Tropical Alexander von Humboldt


Verification Date

May 2019