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RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01154556
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease
HIV Positive

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 Design

Study Type : Observational
Actual Enrollment : 2044 participants
Time Perspective: Retrospective
Official Title: Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice
Study Start Date : June 2010
Primary Completion Date : September 2011
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
HIV1 positive, NNRTI exposure and failure


Outcome Measures

Primary Outcome Measures :
  1. resistance profiling and subsequent prescription patterns of patients on NNRTIs [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154556


Locations
Australia, New South Wales
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Holdsworth House Medical Practice
More Information

Responsible Party: Dr. Mark Bloch, Principal Investigator, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT01154556     History of Changes
Other Study ID Numbers: RETRIeVE
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:
Antiretroviral therapy experienced
failed NNRTI regime

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents