Lead Investigator: Yasuhiro Hagiwara, The University of Tokyo
Title of Proposal Research: Development of Covariate Adjustment Methods to Improve Efficiency of Randomized Clinical Trials for human immunodeficiency virus Infected Patients
Vivli Data Request: 9863
Funding Source: Grant 22K17858 from the Japan Society for the Promotion of Science, KAKENHI
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Drug development requires significant time and financial resources. Despite the remarkable success in treating patients infected with the human immunodeficiency virus (HIV), which causes serious infectious diseases and cancer if left untreated, there remains a need for more effective, safer, and more convenient treatments. Efficient study methodologies that save time and money are essential.
One approach to enhance drug development efficiency is covariate adjustment. This analytical method is used in clinical studies. In typical drug development trials, patients are randomly assigned to either an experimental or a control treatment. Comparing the outcomes of these two groups provides a valid estimate of treatment effect. In HIV drug studies, researchers compare the proportions of patients with HIV levels below a certain threshold. However, covariate adjustment methods provide a more precise estimate of treatment effect than simple comparisons. By incorporating patient characteristics that predict study outcomes, we can reduce random error. Consequently, covariate adjustment reduces the required number of subjects and study duration.
In our study, we introduce a new covariate adjustment method for HIV drug trials, focusing on the proportion of patients achieving virus levels below a specific threshold. We apply this method to an existing HIV drug study and compare its results with those of simple group comparison and existing covariate adjustment methods. Ultimately, our research aims to improve the efficiency of HIV drug studies and enhance the quality of life for future patients living with HIV.
Requested Studies:
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
Data Contributor: GlaxoSmithKline
Study ID: NCT01449929
Sponsor ID: 114915