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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02295384
Enrollment
1104
Registered
2014-11-20
Start date
2014-11-30
Completion date
2016-06-30
Last updated
2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Polypharmacy, Medication Therapy Management

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.

Interventions

OTHERRetrospective Audit

Retrospective Audit

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
Holdsworth House Medical Practice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantity of concomitant medications used in patients with HIV-1 infection9.5 yearsThe pill burden of concomitant medications for patients with HIV-1 infection
Types of concomitant medications used in patients with HIV-1 infection9.5 years

Secondary

MeasureTime frame
Total pill load in patients with HIV9.5 years
Frequency of drug dosing9.5 years
Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)9.5 years

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026