NCT05495204

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

External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 141 (actual)
• Sponsor: Epividian · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Ibalizumab	Participation in clinical trials vs. routine care in OPERA

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-02-20
• Completion: 2023-02-20
• First posted: 2022-08-10
• Last updated: 2023-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study