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Proposal 1622

Title of the Proposed Research

A systematic literature review and Individual patient-level data enhanced network meta-analysis to determine the comparative efficacy and safety of first-line HIV antiretroviral therapies

Lead Researcher

Steve Kanters

Affiliation

School of Population and Public Health

Funding Source

This work will be used towards my PhD thesis and I am funded by the Canadian Institutes of Health Research (CIHR)

Potential Conflicts of Interest

None

Data Sharing Agreement Date

15 May 2017

Lay Summary

In 2015 we lead almost half of the research questions that the World Health Organization had set to answer in order to inform their updated clinical and operational guidelines for the treatment and prevention of HIV using ART. The reason why we covered so many is that we reasoned that newer statistical methods should be used for this process, specifically methods called network meta-analysis. As such, the WHO used these methods for the first time in their guideline development methods. We would now like to expand these analyses by supplementing them with individual patient-level data (IPD). We wish to do this for two reasons. First, to improve the adjustments used to minimize bias within the analyses. By better adjusting for differences across trials, we can better ensure that we are comparing apples to apples, rather than apples to oranges. Second, we wish to use the data to explore an expansion of the statistical methodology that we will be using (NMA).

Study Data Provided

VIIV-ING113086: A randomized, double blind study of the safety and efficacy of GSK1349572 50mg once daily to raltegravir 400mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects
VIIV-ING114467: A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
VIIV-ING114915: A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.