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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTLV-1 plus Tropical Spastic paraparesis | Experimental | Patients with recent onset of Tropical Spastic paraparesis due HTLV-1 will receive combination of "Raltegravir" and "Zidovudine" during 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Raltegravir" and "Zidovudine" | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Gotuzzo, MD | Instituto de Medicina Tropical Alexander von Humboldt | Principal Investigator |
| Fernando MejÃa, MD | Instituto de Medicina Tropical Alexander von Humboldt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Tropical Alexander von Humboldt | Lima | 01 | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17376384 | Result | Verdonck K, Gonzalez E, Van Dooren S, Vandamme AM, Vanham G, Gotuzzo E. Human T-lymphotropic virus 1: recent knowledge about an ancient infection. Lancet Infect Dis. 2007 Apr;7(4):266-81. doi: 10.1016/S1473-3099(07)70081-6. | |
| 9180608 | Result | 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. |
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| ID | Term |
|---|---|
| D015490 | HTLV-I Infections |
| D015493 | Paraparesis, Tropical Spastic |
| ID | Term |
|---|---|
| D006800 | Deltaretrovirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 19578703 | Result | 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. |
| 20573027 | Result | 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. |
| 22227566 | Result | 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. |
| 7760890 | Result | 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. |
| 12522449 | Result | Hermine O, Allard I, Levy V, Arnulf B, Gessain A, Bazarbachi A; French ATL therapy group. A prospective phase II clinical trial with the use of zidovudine and interferon-alpha in the acute and lymphoma forms of adult T-cell leukemia/lymphoma. Hematol J. 2002;3(6):276-82. doi: 10.1038/sj.thj.6200195. |
| 21343468 | Result | Seegulam ME, Ratner L. Integrase inhibitors effective against human T-cell leukemia virus type 1. Antimicrob Agents Chemother. 2011 May;55(5):2011-7. doi: 10.1128/AAC.01413-10. Epub 2011 Feb 22. |
| 21965433 | Result | Trevino A, Parra P, Bar-Magen T, Garrido C, de Mendoza C, Soriano V. Antiviral effect of raltegravir on HTLV-1 carriers. J Antimicrob Chemother. 2012 Jan;67(1):218-21. doi: 10.1093/jac/dkr404. Epub 2011 Sep 29. |
| 15472843 | Result | Gotuzzo E, Cabrera J, Deza L, Verdonck K, Vandamme AM, Cairampoma R, Vizcarra D, Cabada M, Narvarte G, De las Casas C. Clinical characteristics of patients in Peru with human T cell lymphotropic virus type 1-associated tropical spastic paraparesis. Clin Infect Dis. 2004 Oct 1;39(7):939-44. doi: 10.1086/423957. Epub 2004 Sep 1. |
| D007239 |
| Infections |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D013936 |
| Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |