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| Sponsored by: |
Imperial College London |
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00272480 |
Purpose
To determine whether the use of two antiviral agents in combination will be better than placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I
| Condition | Intervention | Phase |
|
HTLV-I-Associated Myelopathy |
Drug: Zidovudine/lamivudine |
Phase II Phase III |
| ChemIDplus related topics: | Zidovudine Lamivudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Zidovudine Plus Lamivudine in HTLV-I-Associated Myelopathy: a Randomised Trial |
| Estimated Enrollment: | 24 |
| Study Start Date: | November 1999 |
| Estimated Study Completion Date: | November 2001 |
Randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine in HAM/TSP 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by 6 months open-label therapy with active drug Primary endpoint: clinical Secondary endpoints: virological and immunological
Eligibility
| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HTLV-I-associated myelopathy -
Exclusion Criteria:
prior exposure to zidovudine or lamvudine on disease modifying therapy under age 16
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Contacts and Locations
More Information
| Taylor GP et al The Bridge Study - A double-blind, placebo controlled trial of zidovudine plus lamivudine for the treatment of patients with HTLV-I-associated myelopathy AIDS Research and Human Retroviruses 2003;19 (suppl 1) #O23 |
| Study ID Numbers: | BRIDGE1.0 |
| First Received: | January 4, 2006 |
| Last Updated: | June 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00272480 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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