RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice | NCT01154556

Studies
RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice

NCT01154556

Sponsor

Holdsworth House Medical Practice

Status

Completed

Last Update Posted

Sep 21, 2015Estimated

Enrollment

2,044Actual

Phase

Not provided

Conditions

HIV Positive

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jun 30, 2010

First Submission Date that Met QC Criteria

Jun 30, 2010

First Posted Date

Jul 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2015

Last Update Posted Date

Sep 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Mark Bloch, Principal Investigator, Holdsworth House Medical PracticePrincipal Investigator

Lead Sponsor

Holdsworth House Medical PracticeOTHER

Collaborators

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,044Actual

Label	Type	Description	Intervention Names
HIV1 positive, NNRTI exposure and failure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: N/A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holdsworth House Medical Practice		Darlinghurst	New South Wales	2010	Australia

Condition Browse Module

MeSH Terms

ID	Term
D006679	HIV Seropositivity

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided