Condition category
Infections and Infestations
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15793365

Publication citations

  1. 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.

Additional files

Editorial Notes