A randomised controlled trial to assess the role of resistance assays in Human Immunodeficiency Virus (HIV) infection
ISRCTN | ISRCTN45898562 |
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DOI | https://doi.org/10.1186/ISRCTN45898562 |
Secondary identifying numbers | RDC01658 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/04/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Dunn
Scientific
Scientific
MRC Clinical Trials
222 Euston Road
London
NW1 2DA
United Kingdom
Phone | +44 (0)20 7670 4739 |
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d.dunn@ctu.mrc.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Not Specified |
Scientific title | |
Study acronym | ERA - Evaluation of Resistance Assays |
Study objectives | The main hypothesis is that providing genotypic resistance assays improves the treatment of HIV-infected individuals who are not highly treatment-experienced. A subsidiary hypothesis is that phenotypic plus genotypic resistance testing is superior to genotypic resistance testing alone in HIV-infected individuals who are highly treatment-experienced. The ERA trial was designed to assess the clinical utility of HIV resistance testing in patients who had failed therapy and whose most recent viral load was at least 2000 copies/ml. Patients were randomised to one of two parts, depending on whether the clinician was able (Part A) or was not able (Part B) to select a regimen of 3 or more drugs that, with reasonable expectation, had potent anti-HIV activity and to which each drug contributed. Patients in Part A were allocated to (a) no resistance test, or (b) a centralised genotypic assay (VIRCOGENTM). All participants in Part B had the VIRCOGENTM assay and were randomised to have or not have in addition a centralised phenotypic assay (ANTIVIROGRAMTM). Patients allocated to resistance testing had access to testing at any time during follow-up when clinically indicated, according to the original allocation. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Infection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS) |
Intervention | 1. Standard care 2. Access to a centralised genotypic assay with computer assisted interpretation 3. Access to a centralised phenotypic assay |
Intervention type | Other |
Primary outcome measure | Plasma HIV-1 RNA at 12 months measured centrally at the Royal Free Hospital using the Roche ultra-sensitive assay (with a lower limit of detection of 50 copies/ml). |
Secondary outcome measures | 1. CD4 count at 12 months (all laboratories participate in the UK National Quality Assessment Scheme of SD4) 2. Antiretroviral treatment prescribed including the number of switches in therapy and drugs used (constructed from 3-monthly case record forms) 3. Adherence with antiretroviral treatment prescribed (assessed by a 3-monthly self-completed questionnaire) 4. Available drug options (as assessed by genotypic resistance) at 12 months 5. Progression to a new AIDS-defining events will be collected retrospectively on an annual basis after 12 months to enable long-term benefits to be assessed |
Overall study start date | 01/02/2000 |
Completion date | 01/08/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 480 |
Key inclusion criteria | 1. Confirmed HIV-positive 2. Age 18 years or more 3. Expected to live at least 12 months 4. Able to give informed consent 5. Currently receiving antiretroviral therapy 6. Most recent HIV ribonucleic acid (RNA) >2000 copies/ml 7. Clinician and patients have decided to change therapy on the basis of virological failure 8. Clinician considers that a resistance test may influence selection of new drug regimen, and clinician and patient are prepared to wait for the result (up to 1 month) before changing treatment |
Key exclusion criteria | 1. Naive to antiretroviral drugs or previous exposure to 1 or 2 nucleoside analogue reverse transcriptase inhibitors only 2. Part A only: a resistance test (genotypic or phenotypic) had previously been performed or patient would have had a local resistance test 3. Part B only: a phenotypic resistance test had previously been performed 4. Participation in certain trials of antiretroviral therapies, considered on a case-by-case basis 5. Was unlikely to comply with routine schedule of visits |
Date of first enrolment | 01/02/2000 |
Date of final enrolment | 01/08/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 15/04/2005 | Yes | No |