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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
For the majority of patients, management of HIV-1 infection involves effective and well
tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the
availability of single tablet regimens (STRs) with single tablet once daily dosing. STR
therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013;
Sax et al., 2012).

However, the aging of the HIV cohort in Australia and globally has raised issues of
increasing co-morbidities and consequent polypharmacy to manage these (Jansson & Wilson,
2012; Edelman et al., 2013).

Polypharmacy may not only impact on adherence, but also increases the potential for drug-drug
interactions (Holtzman et al., 2013).

Stribild, a highly effective STR, contains cobicistat to boost the levels of the component
integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but acts
by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized via
this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014).
Additionally there is evidence of increased risk of nephrotoxicity with co-administration of
tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008).

Data on use of concomitant medications in Australian patients with HIV is sparse. This study
aims to determine, in a large caseload community HIV practice, the use of concomitant
medications in HIV, patient pill load and dosing frequency, and potential drug-drug
interactions with stribild.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02295384
Trial related presentations / publications
Jansson J, Wilson DP. Projected demographic profile of people living with HIV in Australia: planning for an older generation. PLoS One. 2012;7(8):e38334. doi: 10.1371/journal.pone.0038334. Epub 2012 Aug 9.
Edelman EJ, Gordon KS, Glover J, McNicholl IR, Fiellin DA, Justice AC. The next therapeutic challenge in HIV: polypharmacy. Drugs Aging. 2013 Aug;30(8):613-28. doi: 10.1007/s40266-013-0093-9.
Holtzman C, Armon C, Tedaldi E, Chmiel JS, Buchacz K, Wood K, Brooks JT; , and the HOPS Investigators. Polypharmacy and risk of antiretroviral drug interactions among the aging HIV-infected population. J Gen Intern Med. 2013 Oct;28(10):1302-10. doi: 10.1007/s11606-013-2449-6. Epub 2013 Apr 20.
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