Brief Summary

To compare two commercially available platforms for assessment of HIV drug resistance to determine which provides superior virological results. We hypothesise that one test will be significantly superior to the other.

Trial Health

On Track

Trial Health Score

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

Enrollment

338

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach

1 country

19 active sites

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

5.4 years study duration

Study Start

First participant enrolled

March 1, 2001

Completed

4.8 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2006

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2006

Completed

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

4.9 years

First QC Date

December 6, 2005

Last Update Submit

June 23, 2025

Conditions

HIV Infection

Keywords

HIV drug resistance testingTreatment Experienced

Outcome Measures

Primary Outcomes (1)

The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
at 48 weeks follow-up

Secondary Outcomes (1)

Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen
at 48 weeks

Study Arms (2)

Group A: subjects assign to receive a GENOTYPE

EXPERIMENTAL

randomised prior to the selection of their new cART regimen

Diagnostic Test: Blood test: genotype testing

Group B: subjects assign to receive a VIRTUAL PHENOTYPE

EXPERIMENTAL

randomised prior to the selection of their new cART regimen

Diagnostic Test: Blood test: genotype testing

Interventions

Blood test: genotype testingDIAGNOSTIC_TEST

Group A: subjects assign to receive a GENOTYPEGroup B: subjects assign to receive a VIRTUAL PHENOTYPE

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA\> 2000copies/mL, who were willing to change ARVs and who provided informed consent.

You may not qualify if:

Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.

Contact the study team to confirm eligibility.

Study Sites (19)

Interchange General Practice

Canberra, Australian Capital Territory, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Sydney Sexual Health Clinic

Sydney, New South Wales, 2000, Australia

Location

AIDS Research Initiative