NCT01940198

Brief Summary

This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

June 1, 2010

Last Update Submit

September 8, 2013

Conditions

Keywords

Atazanavirlong-termprimary care settingsydney

Outcome Measures

Primary Outcomes (1)

  • Proportion of HIV-1 infected participants with atazanavir experience

    Proportion of patients who continue on atazanavir for 2 years or greater from baseline to termination/current.

    1 year

Secondary Outcomes (4)

  • Proportion of HIV-1 infected participants with atazanavir experience

    1 year

  • Proportion of HIV-1 infected participants with atazanavir experience

    1 year

  • Proportion of HIV-1 infected participants with atazanavir experience

    1 year

  • Proportion of HIV-1 infected participants with atazanavir experience

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of HIV-1 positive patients attending Holdsworth House Medical Practice who have commenced ATV as a component of ART will be identified from review of current database. Data will be collected retrospectively from patient electronic medical records for HIV-1 positive patients that have commenced ATV from year 2002 - 2008.

You may qualify if:

  • HIV-1 positive
  • Have commenced ATV between 2002-2008 (Baseline)
  • Follow-up data (clinical and laboratory) available from baseline

You may not qualify if:

  • Patients not commenced ATV between 2002-2008
  • No follow-up data (clinical and laboratory) available from baseline
  • Patient 'lost to follow-up' with \< 2 years of follow-up data (Clinical and laboratory)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Study Officials

  • Mark Bloch, Dr.

    Holdsworth House Medical Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2010

First Posted

September 12, 2013

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2012

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations