HTLV-I-associated MyelopathyPhase 2/3NCT00272480
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
A Phase 2/3 study testing Zidovudine/lamivudine in people with HTLV-I-associated Myelopathy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- HTLV-I-associated Myelopathy
- What is being tested?
- Zidovudine/lamivudine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 1999to 30 Jul 2002
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HTLV-I-associated myelopathy
Who cannot join
- prior exposure to zidovudine or lamivudine on disease modifying therapy
- under age 16
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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
- Conditions
- HTLV-I-associated Myelopathy
- Being tested
- Zidovudine/lamivudine, Placebos
- Keywords
- HAM/TSP, HTLV-I-associated myelopathy, zidovudine, lamivudine, antiretroviral therapy
- Medical subject headings
- Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zidovudine/lamivudineDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo in HAM/TSP 24 Receives: Drug: Placebos |
| Zidvoudine plus lamivudine | Active comparator | Zidvoudine plus lamivudine in HAM/TSP 24 Receives: Drug: Zidovudine/lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed walk
Time taken to walk 13m
Measured: 6 months
Osame's Motor Disability Score
0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
Measured: 6 months
Pain score
11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
Measured: 6 months
Urinary frequency
Number of times passing urine during the daytime
Measured: 6 months
HTLV-1 proviral load
The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
Measured: 6 months
Secondary outcomes (2)
CD25%
Expression of CD25 on T-cells
Measured: 6 months
HLA-DR%
Expression of HLA-DR on T-cells
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study start8 Nov 1999
- Primary completion30 Jul 2002
- Study completion30 Jul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HTLV-I-associated MyelopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graham P Taylor, FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272480
- Sponsor's protocol ID
- BRIDGE1.0
- Status last verified
- Aug 2021
- First submitted
- 4 Jan 2006
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Taylor GP, Goon P, Furukawa Y, Green H, Barfield A, Mosley A, Nose H, Babiker A, Rudge P, Usuku K, Osame M, Bangham CR, Weber JN. Zidovudine plus lamivudine in Human T-Lymphotropic Virus type-I-associated myelopathy: a randomised trial. Retrovirology. 2006 Sep 19;3:63. doi: 10.1186/1742-4690-3-63.
PubMed 16984654
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
- ClinicalTrials.gov ID
- NCT00272480
- Acronym / sponsor ID
- BRIDGE1.0
- Conditions
- HTLV-I-associated Myelopathy
- Keywords
- HAM/TSP, HTLV-I-associated myelopathy, zidovudine, lamivudine, antiretroviral therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 8 Nov 1999 (actual)
- Primary completion
- 30 Jul 2002 (actual)
- Study completion
- 30 Jul 2002 (actual)
- First posted
- 6 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlacebosPlacebo in HAM/TSP 24 |
| Zidvoudine plus lamivudine | Active comparator | Drug: Zidovudine/lamivudineZidvoudine plus lamivudine in HAM/TSP 24 |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HTLV-I-associated myelopathy
Key exclusion criteria (2 listed)
- prior exposure to zidovudine or lamivudine on disease modifying therapy
- under age 16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine/lamivudine | Drug | Zidvoudine plus lamivudine |
| Placebos | Drug | Placebo |
Primary outcome
Timed walk
Time frame: 6 months
Time taken to walk 13m
Osame's Motor Disability Score
Time frame: 6 months
0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk)
Pain score
Time frame: 6 months
11 point Visual Analogue Scale 0 = no pain, 10 = worse pain
Urinary frequency
Time frame: 6 months
Number of times passing urine during the daytime
HTLV-1 proviral load
Time frame: 6 months
The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells
2 secondary outcomes
CD25%
Time frame: 6 months
HLA-DR%
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- BackgroundTaylor 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
- Results publication: PubMed 16984654Taylor GP, Goon P, Furukawa Y, Green H, Barfield A, Mosley A, Nose H, Babiker A, Rudge P, Usuku K, Osame M, Bangham CR, Weber JN. Zidovudine plus lamivudine in Human T-Lymphotropic Virus type-I-associated myelopathy: a randomised trial. Retrovirology. 2006 Sep 19;3:63. doi: 10.1186/1742-4690-3-63.
- Individual participant dataSharing planned: No
Related trials for HTLV-I-associated Myelopathy
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingPhase 1/2
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
HAM/TSP
RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
HTLV-1 Infection, HTLV I Associated Myelopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham P Taylor, FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zidovudine/lamivudine in people with HTLV-I-associated Myelopathy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed walk (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00272480, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.