An observational study in HIV, sponsored by Holdsworth House Medical Practice. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-12.
Sponsored by Holdsworth House Medical Practice · Observational
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.
Holdsworth House Medical Practice is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-infected patients attending HHMP from 1st January 2005 to 31st July 2014 inclusive, who had at least 2 practice visits separated by ≥90 days in a year involving HIV laboratory monitoring whilst attending HHMP (either on-site or at a co-management site).
Exclusion Criteria:
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: Retrospective Audit
Retrospective Audit
Quantity of concomitant medications used in patients with HIV-1 infection
The pill burden of concomitant medications for patients with HIV-1 infection
Time frame: 9.5 years
Types of concomitant medications used in patients with HIV-1 infection
Time frame: 9.5 years
Total pill load in patients with HIV
Time frame: 9.5 years
Frequency of drug dosing
Time frame: 9.5 years
Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)
Time frame: 9.5 years
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Holdsworth House Medical Practice