Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia

HIV Clinical Trial

Official title:

Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295384
• Other study ID #: Polypharmacy Audit
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: September 8, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethic Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1104
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Retrospective Audit
Retrospective Audit

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice	Gilead Sciences

Country where clinical trial is conducted

Australia, 

References & Publications (6)

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. — View Citation

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). pii: e003028. do — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of concomitant medications used in patients with HIV-1 infection	The pill burden of concomitant medications for patients with HIV-1 infection	9.5 years	No
Primary	Types of concomitant medications used in patients with HIV-1 infection		9.5 years	No
Secondary	Total pill load in patients with HIV		9.5 years	No
Secondary	Frequency of drug dosing		9.5 years	No
Secondary	Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)		9.5 years	No

External Links

•   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)