Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia
NCT ID: NCT02295384
Last Updated: 2016-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1104 participants
OBSERVATIONAL
2014-11-30
2016-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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)).
Retrospective Audit
Retrospective Audit
Interventions
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Retrospective Audit
Retrospective Audit
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Incomplete/inaccessible patient records
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Holdsworth House Medical Practice
OTHER
Responsible Party
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Dr. Mark Bloch
Principle Investigator
Principal Investigators
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Mark Bloch, MBBS, M Med
Role: PRINCIPAL_INVESTIGATOR
Holdsworth House Medical Practice
Locations
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Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
Countries
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References
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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.
Cohen CJ, Meyers JL, Davis KL. Association between daily antiretroviral pill burden and treatment adherence, hospitalisation risk, and other healthcare utilisation and costs in a US medicaid population with HIV. BMJ Open. 2013 Aug 1;3(8):e003028. doi: 10.1136/bmjopen-2013-003028.
Sax PE, Meyers JL, Mugavero M, Davis KL. Adherence to antiretroviral treatment and correlation with risk of hospitalization among commercially insured HIV patients in the United States. PLoS One. 2012;7(2):e31591. doi: 10.1371/journal.pone.0031591. Epub 2012 Feb 24.
Bpharm SM, Talbot A, Trottier B. Acute renal failure in four HIV-infected patients: Potential association with tenofovir and nonsteroidal anti-inflammatory drugs. Can J Infect Dis Med Microbiol. 2008 Jan;19(1):75-6. doi: 10.1155/2008/370535. No abstract available.
Related Links
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Co-prescription of Non-HIV Medications in HIV-Infected Individuals in 5 European Countries and the Possible Impact of Interactions With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (E/C/F/TDF)
Other Identifiers
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Polypharmacy Audit
Identifier Type: -
Identifier Source: org_study_id
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