A randomised controlled trial to assess the role of resistance assays in Human Immunodeficiency Virus (HIV) infection

ISRCTN ISRCTN45898562
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

MRC Clinical Trials
222 Euston Road
London
NW1 2DA
United Kingdom

Phone +44 (0)20 7670 4739
Email d.dunn@ctu.mrc.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study acronymERA - Evaluation of Resistance Assays
Study objectivesThe 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) studiedInfection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS)
Intervention1. Standard care
2. Access to a centralised genotypic assay with computer assisted interpretation
3. Access to a centralised phenotypic assay
Intervention typeOther
Primary outcome measurePlasma 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 measures1. 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 date01/02/2000
Completion date01/08/2002

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants480
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2000
Date of final enrolment01/08/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials
London
NW1 2DA
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 15/04/2005 Yes No