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

Completed

• Conditions: HIV-1-infection
• Interventions: Drug: Ibalizumab

• Registration Number: NCT05495204
• Lead Sponsor: Epividian

Brief 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.

Study Timeline

• Study Start: 2022-08-05
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBA+OBR (trials)	Ibalizumab	Participants in TMB-202 or TMB-301/311 trials who received 800 mg ibalizumab every 2 weeks, with or without a loading dose

Primary Outcome Measures

Name	Time	Method
Viral suppression	Week 96	Viral load \<200 copies/mL
Viral undetectability	Week 96	Viral load \<50 copies/mL

Trial Locations

Locations (1)

Epividian; 🇺🇸 Durham, North Carolina, United States