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RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:
NCT01154556
First received: June 30, 2010
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

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
HIV Positive

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice

Resource links provided by NLM:


Further study details as provided by Holdsworth House Medical Practice:

Primary Outcome Measures:
  • resistance profiling and subsequent prescription patterns of patients on NNRTIs [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV1 positive, NNRTI exposure and failure

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Mark Bloch, Principal Investigator, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT01154556     History of Changes
Other Study ID Numbers: RETRIeVE
Study First Received: June 30, 2010
Last Updated: September 8, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Holdsworth House Medical Practice:
Antiretroviral therapy experienced
failed NNRTI regime

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

ClinicalTrials.gov processed this record on November 20, 2014