RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice

September 17, 2015 updated by: Dr. Mark Bloch, Holdsworth House Medical Practice

Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice

An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs

Study Overview

Status

Completed

Conditions

Detailed Description

This is a cross-sectional study involving retrospective review of HIV-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and subsequently failed. Patients who have virologically failed previous NNRTI treatment, or have resistance to 1 drug in the NNRTI class are examined further. Such patients will have attended the clinic every 3-6 months for routine medical care. The data source for variables collected is the patient's electronic medical records. This database is located at Holdsworth House Medical Practice (HHMP), Sydney.

Study Type

Observational

Enrollment (Actual)

2044

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Demographic information will be collected from patient medical records for all patients that have used previously, or are currently using an NNRTI as part of HIV treatment therapy.

Description

Inclusion Criteria:

  1. Documented HIV infection
  2. Attended Holdsworth House Medical Practice 1999-2009.
  3. Chosen ART regime includes an NNRTI

Exclusion Criteria: N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV1 positive, NNRTI exposure and failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
resistance profiling and subsequent prescription patterns of patients on NNRTIs
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holdsworth House Medical Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETRIeVE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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