Contact information
Type
Scientific
Primary contact
Dr David Dunn
ORCID ID
Contact details
MRC Clinical Trials
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4739
d.dunn@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC01658
Study information
Scientific title
Acronym
ERA - Evaluation of Resistance Assays
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/02/2000
Overall trial end date
01/08/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
480
Participant 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
Recruitment start date
01/02/2000
Recruitment end date
01/08/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Dunn DT, Green H, Loveday C, Rinehart A, Pillay D, Fisher M, McCormack S, Babiker AG, Darbyshire JH, , A randomized controlled trial of the value of phenotypic testing in addition to genotypic testing for HIV drug resistance: evaluation of resistance assays (ERA) trial investigators., J. Acquir. Immune Defic. Syndr., 2005, 38, 5, 553-559.