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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495204
• Other study ID #: COL2022-001
• Status: Completed
• Start date: August 5, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: September 2023
• Source: Epividian
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Trial IBA+OBR group):

• Participant in TMB-202 or TMB-301/311

• Received 800 mg IBA every 2 weeks, with or without a loading dose

Inclusion Criteria (OPERA non-IBA OBR group):

• 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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Ibalizumab
Participation in clinical trials vs. routine care in OPERA

Locations

Country	Name	City	State
United States	Epividian	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Epividian	FIECON, Theratechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	Viral load <200 copies/mL	Week 24
Primary	Viral suppression	Viral load <200 copies/mL	Week 48
Primary	Viral suppression	Viral load <200 copies/mL	Week 60
Primary	Viral suppression	Viral load <200 copies/mL	Week 96
Primary	Viral undetectability	Viral load <50 copies/mL	Week 24
Primary	Viral undetectability	Viral load <50 copies/mL	Week 48
Primary	Viral undetectability	Viral load <50 copies/mL	Week 60
Primary	Viral undetectability	Viral load <50 copies/mL	Week 96