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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN45898562
• Date of registration: 23/01/2004
• Prospective Registration: No
• Primary sponsor: NHS R&D Regional Programme Register - Department of Health (UK)
• Public title: A randomised controlled trial to assess the role of resistance assays in Human Immunodeficiency Virus (HIV) infection
• Date of first enrolment: 01/02/2000
• Target sample size: 480
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN45898562
• Study type: Interventional
• Study design: Randomised controlled trial (Not Specified)

Countries of recruitment

United Kingdom

Contacts

• Name: David Dunn

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Infection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS)
Infections and Infestations
HIV/Acquired Immunodeficiency Syndrome (AIDS)

Intervention(s)

1. Standard care
2. Access to a centralised genotypic assay with computer assisted interpretation
3. Access to a centralised phenotypic assay

Primary Outcome(s)

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(s)

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

Secondary ID(s)

RDC01658

Source(s) of Monetary Support

NHS Executive London