HTLV-I Infections, Tropical Spastic Paraparesis
Conditions
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.
Interventions
DRUGRaltegravir and Zidovudine
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
Sponsors
Merck Sharp & Dohme LLC
Universidad Peruana Cayetano Heredia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of proviral load | 48 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Measure of Disability Scale | 48 weeks | 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. |
Countries
Peru
Outcome results
None listed