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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"
Sponsored by
Universidad Peruana Cayetano Heredia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
November 16, 2015
Last Updated
May 20, 2019
Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Merck Sharp & Dohme LLC
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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
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

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
No
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
01
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
result
PubMed Identifier
19578703
Citation
Primo J, Siqueira I, Nascimento MC, Oliveira MF, Farre L, Carvalho EM, Bittencourt AL. High HTLV-1 proviral load, a marker for HTLV-1 associated myelopathy/tropical spastic paraparesis, is also detected in patients with infective dermatitis associated with HTLV-1. Braz J Med Biol Res. 2009 Aug;42(8):761-4. doi: 10.1590/s0100-879x2009005000008. Epub 2009 Jul 3.
Results Reference
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PubMed Identifier
20573027
Citation
Izumo S. Neuropathology of HTLV-1-associated myelopathy (HAM/TSP): The 50th Anniversary of Japanese Society of Neuropathology. Neuropathology. 2010 Oct;30(5):480-5. doi: 10.1111/j.1440-1789.2010.01135.x.
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PubMed Identifier
22227566
Citation
Varrin-Doyer M, Nicolle A, Marignier R, Cavagna S, Benetollo C, Wattel E, Giraudon P. Human T lymphotropic virus type 1 increases T lymphocyte migration by recruiting the cytoskeleton organizer CRMP2. J Immunol. 2012 Feb 1;188(3):1222-33. doi: 10.4049/jimmunol.1101562. Epub 2012 Jan 6.
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PubMed Identifier
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Citation
Gill PS, Harrington W Jr, Kaplan MH, Ribeiro RC, Bennett JM, Liebman HA, Bernstein-Singer M, Espina BM, Cabral L, Allen S, et al. Treatment of adult T-cell leukemia-lymphoma with a combination of interferon alfa and zidovudine. N Engl J Med. 1995 Jun 29;332(26):1744-8. doi: 10.1056/NEJM199506293322603.
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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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Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection

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