Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02295384




Registration number
NCT02295384
Ethics application status
Date submitted
17/11/2014
Date registered
20/11/2014
Date last updated
12/09/2016

Titles & IDs
Public title
Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia
Scientific title
Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia
Secondary ID [1] 0 0
Polypharmacy Audit
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Retrospective Audit

Audit Group - Patients attending HHMP in Darlinghurst, Sydney, New South Wales with documented HIV-1 infection from 1st January 2005 to 31st July 2014, who were considered "linked to care" (Attendance during the study period for at least 2 visits \>3 months and \<12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site)).


Other interventions: Retrospective Audit
Retrospective Audit
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quantity of concomitant medications used in patients with HIV-1 infection
Timepoint [1] 0 0
9.5 years
Primary outcome [2] 0 0
Types of concomitant medications used in patients with HIV-1 infection
Timepoint [2] 0 0
9.5 years
Secondary outcome [1] 0 0
Total pill load in patients with HIV
Timepoint [1] 0 0
9.5 years
Secondary outcome [2] 0 0
Frequency of drug dosing
Timepoint [2] 0 0
9.5 years
Secondary outcome [3] 0 0
Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)
Timepoint [3] 0 0
9.5 years

Eligibility
Key inclusion criteria
* Documented HIV-1 infection
* Attendance during the study period for at least 2 visits >3 months and <12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count
* Incomplete/inaccessible patient records

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
1104
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Bloch, MBBS, M Med
Address 0 0
Holdsworth House Medical Practice
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT02295384