Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic … (NCT02655471) | Clinical Trial Compass
CompletedEarly Phase 1
Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection
Peru10 participantsStarted 2017-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.