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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01154556
Other study ID # RETRIeVE
Secondary ID
Status Completed
Phase N/A
First received June 30, 2010
Last updated September 17, 2015
Start date June 2010
Est. completion date February 2013

Study information

Verified date September 2015
Source Holdsworth House Medical Practice
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 2044
Est. completion date February 2013
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Holdsworth House Medical Practice Darlinghurst New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Holdsworth House Medical Practice

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary resistance profiling and subsequent prescription patterns of patients on NNRTIs 1 year No
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