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

Primary Purpose

HTLV-I Infections, Tropical Spastic Paraparesis

Status

Completed

Phase

Early Phase 1

Locations

Peru

Study Type

Interventional

Intervention

"Raltegravir" and "Zidovudine"

About this trial

This is an interventional treatment trial for HTLV-I Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto de Medicina Tropical Alexander von Humboldt

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HTLV-1 plus Tropical Spastic paraparesis

Arm Description

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

Outcomes

Primary Outcome Measures

Measure of proviral load

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

Measure of Disability Scale

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.

Full Information

NCT ID

NCT02655471

First Posted

November 16, 2015

Last Updated

May 20, 2019

Sponsor

Universidad Peruana Cayetano Heredia

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02655471

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

March 15, 2019 (Actual)

Study Completion Date

March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Peruana Cayetano Heredia

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HTLV-I Infections, Tropical Spastic Paraparesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HTLV-1 plus Tropical Spastic paraparesis

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

"Raltegravir" and "Zidovudine"

Other Intervention Name(s)

"Raltegravir", "Zidovudine"

Intervention Description

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

Primary Outcome Measure Information:

Title

Measure of proviral load

Description

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.

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Measure of Disability Scale

Description

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.

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Gotuzzo, MD

Organizational Affiliation

Instituto de Medicina Tropical Alexander von Humboldt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernando Mejía, MD

Organizational Affiliation

Instituto de Medicina Tropical Alexander von Humboldt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Medicina Tropical Alexander von Humboldt

City

Lima

ZIP/Postal Code

Country

Peru

12. IPD Sharing Statement

Citations:

PubMed Identifier

17376384

Citation

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Results Reference

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PubMed Identifier

9180608

Citation

Zurita S, Costa C, Watts D, Indacochea S, Campos P, Sanchez J, Gotuzzo E. Prevalence of human retroviral infection in Quillabamba and Cuzco, Peru: a new endemic area for human T cell lymphotropic virus type 1. Am J Trop Med Hyg. 1997 May;56(5):561-5. doi: 10.4269/ajtmh.1997.56.561.

Results Reference

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PubMed Identifier

19578703

Citation

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PubMed Identifier

20573027

Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Results Reference

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

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