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

Completed

• Conditions: HIV
• Interventions: Other: Retrospective Audit

• Registration Number: NCT02295384
• Lead Sponsor: Holdsworth House Medical Practice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Audit Group	Retrospective Audit	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)).

Primary Outcome Measures

Name	Time	Method
Types of concomitant medications used in patients with HIV-1 infection	9.5 years
Quantity of concomitant medications used in patients with HIV-1 infection	9.5 years	The pill burden of concomitant medications for patients with HIV-1 infection

Secondary Outcome Measures

Name	Time	Method
Frequency of drug dosing	9.5 years
Total pill load in patients with HIV	9.5 years
Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)	9.5 years

Trial Locations

Locations (1)

Holdsworth House Medical Practice; 🇦🇺 Darlinghurst, New South Wales, Australia