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Clinical Trials/ISRCTN45898562
ISRCTN45898562
Completed
Not Applicable

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

HS R&D Regional Programme Register - Department of Health (UK)0 sites480 target enrollmentJanuary 23, 2004
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ConditionsInfection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS)Infections and InfestationsHIV/Acquired Immunodeficiency Syndrome (AIDS)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection and infestations: HIV/Acquired Immunodeficiency Syndrome (AIDS)
Sponsor
HS R&D Regional Programme Register - Department of Health (UK)
Enrollment
480
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 23, 2004
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
HS R&D Regional Programme Register - Department of Health (UK)

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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