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OpenTrials
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NCT Number: NCT02295384

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective Audit

Other

Retrospective Audit

Primary outcomes

  1. Quantity of concomitant medications used in patients with HIV-1 infection

    Time frame: 9.5 years

    The pill burden of concomitant medications for patients with HIV-1 infection

  2. Types of concomitant medications used in patients with HIV-1 infection

    Time frame: 9.5 years

Secondary outcomes

  1. Total pill load in patients with HIV

    Time frame: 9.5 years

  2. Frequency of drug dosing

    Time frame: 9.5 years

  3. Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)

    Time frame: 9.5 years

Sponsors and collaborators

Lead sponsor

Holdsworth House Medical Practice

Other

Collaborators

  • Gilead Sciences

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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