NCT01154556

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,044

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

June 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

June 30, 2010

Last Update Submit

September 17, 2015

Conditions

HIV Positive

Keywords

Antiretroviral therapy experiencedfailed NNRTI regime

Outcome Measures

Primary Outcomes (1)

  • resistance profiling and subsequent prescription patterns of patients on NNRTIs

    1 year

Study Arms (1)

HIV1 positive, NNRTI exposure and failure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

February 1, 2013

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

AU(1)