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

NCT ID: NCT05495204

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-02-20

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.

Conditions

HIV-1-infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

IBA+OBR (trials)

Participants in TMB-202 or TMB-301/311 trials who received 800 mg ibalizumab every 2 weeks, with or without a loading dose

Ibalizumab

Intervention Type: DRUG

Participation in clinical trials vs. routine care in OPERA

Non-IBA+OBR (OPERA)

Heavily treatment experienced adults living with HIV in care in OPERA, with documented resistance to ≥1 ARV from each of three ARV classes switching to a new regimen that does not include ibalizumab

No interventions assigned to this group

Interventions

Ibalizumab

Participation in clinical trials vs. routine care in OPERA

Intervention Type: DRUG

Other Intervention Names

Regimens not containing ibalizumab

Eligibility Criteria

Inclusion Criteria

• Participant in TMB-202 or TMB-301/311
• Received 800 mg IBA every 2 weeks, with or without a loading dose

• HIV-1 infection
• 18 years or older
• Heavily treatment experienced (i.e., ever on a regimen containing either DTG BID or DRV BID)
• Documented resistance to ≥1 ARV from each of three ARV classes
• Genotype information available for all the relevant gene regions (see Table 2)
• Viral load > 200 copies/mL at index regimen initiation
• Not pregnant at index
• No new AIDS defining event within 3 months before/on index (except cutaneous Kaposi's sarcoma or HIVAW)
• No new cancer diagnosis within 12 weeks before/on index
• No IBA prescribed prior to/with the index regimen
• Index regimen does not include cabotegravir, fostemsavir, investigational drugs
• Viral sensitivity/susceptibility to at least one ARV in the index regimen
• Baseline VL available (within 6 months before/at index)
• Baseline CD4 available (within 6 months before/at index)
• ≥1 VL measurement at any time after index

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theratechnologies

INDUSTRY

Sponsor Role: collaborator

FIECON

UNKNOWN

Sponsor Role: collaborator

Epividian

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Epividian

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COL2022-001

Identifier Type: -

Identifier Source: org_study_id