Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

Imperial College London

Status and phase: Completed; Phase 3; Phase 2

Conditions: HTLV-I-associated Myelopathy

Treatments: Drug: Placebos; Drug: Zidovudine/lamivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT00272480

BRIDGE1.0

Details and patient eligibility

About

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

Full description

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

Enrollment: 16 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HTLV-I-associated myelopathy

Exclusion criteria

• prior exposure to zidovudine or lamivudine on disease modifying therapy
• under age 16

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo in HAM/TSP 24

Treatment:

Drug: Placebos

Zidvoudine plus lamivudine

Active Comparator group

Description:

Zidvoudine plus lamivudine in HAM/TSP 24

Treatment:

Drug: Zidovudine/lamivudine