Clinical Study Data Request Registered Users, Please Login


Proposal 1456

Title of the Proposed Research

Impact of ongoing side effects on the efficacy of initial antiretroviral therapy

Lead Researcher

Andrew Carr

Affiliation

St Vincent's Hospital, Sydney

Funding Source

This work does not require funding - the investigators will undertake the project within their allocated research time.

Potential Conflicts of Interest

Lead Researcher:

AC has received research grant support from BMS, Gilead, MSD, Pfizer and ViiV Healthcare; participated in advisory boards for Gilead, MSD, and ViiV Healthcare; and received honoraria from Gilead, MSD, and ViiV Healthcare.

Statistician:

SK has no conflict of interest.

Data Sharing Agreement Date

27 July 2016

Lay Summary

HIV medications need to be safe, effective and well tolerated to be able to control HIV indefinitely. The current way of estimating treatment effectiveness requires that a person take the treatment without change and for full control of HIV. However, if a person has side effects from the HIv treatment, but continues to take it, the treatment is regarded as successful. This would mean that permanent side effects are regarded as unimportant. We propose to analyse data from two studies using the existing method, and compare it to a new method in which treatment is regarded as successful if is not only controls HIV and is taken continuously, but also does not cause side effects, and does not require of other medications to control drug side effects.

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.