External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Status Completed

Clinical Trial Summary

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

Clinical Trial Description

The US Department of Health and Human Services (DHHS) HIV treatment guideline suggest that ibalizumab may be considered in the context of multidrug resistance without fully active ART options. However, clinical trials assessing ibalizumab efficacy did not include an active comparison arm in which participants did not receive ibalizumab. The use of external controls can provide valuable information and context to interpret the results of clinical trials when randomization to a control arm cannot be performed. The OPERA (Observational Pharmaco-Epidemiology Research & Analysis) cohort, a large US electronic health record database, is well suited for this as the OPERA and trials populations arose from the same geographic location (i.e., US). An external comparison of ibalizumab + optimized background regimen from trials vs. non-ibalizumab containing regimens in routine clinical care in the OPERA cohort may confirm results from prior studies suggesting viral control benefits of ibalizumab. ;

Study Design

Related Conditions & MeSH terms

HIV-1-infection

Clinical Trial Details

NCT number	NCT05495204
Study type	Observational
Source	Epividian
Contact
Status	Completed
Phase
Start date	August 5, 2022
Completion date	February 20, 2023

View Details

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