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

NCT05495204 | Completed FDA Drug

• 1 other identifier: COL2022-001
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

Heavily treatment experienced; External comparison; Ibalizumab; Virologic effectiveness

Outcome Measures

Primary Outcomes (8)

• Viral suppression

  Viral load \<200 copies/mL

  Week 24

• Viral suppression

  Viral load \<200 copies/mL

  Week 48

• Viral suppression

  Viral load \<200 copies/mL

  Week 60

• Viral suppression

  Viral load \<200 copies/mL

  Week 96

• Viral undetectability

  Viral load \<50 copies/mL

  Week 24

• Viral undetectability

  Viral load \<50 copies/mL

  Week 48

• Viral undetectability

  Viral load \<50 copies/mL

  Week 60

• Viral undetectability

  Viral load \<50 copies/mL

  Week 96

Study Arms (2)

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

Drug: Ibalizumab

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

Interventions

Ibalizumab DRUG

Participation in clinical trials vs. routine care in OPERA

Also known as: Regimens not containing ibalizumab

IBA+OBR (trials)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All TMB-202 and TMB-301/311 trial participants randomized to 800 mg IBA every 2 weeks with or without a loading dose will be included in the main analyses. From the OPERA cohort, adult PWH with resistance from three ARV classes will be considered for inclusion. People with HIV in OPERA initiating a new non-IBA OBR between 01JAN2008 and 31DEC2020 will be included; person-time will be censored at the first of (a) initiation of a select potent ARV, (b) \>45 days without ART, (c) 12 months after last clinical contact, (d) death, or (e) study end.

You may qualify if:

• Participant in TMB-202 or TMB-301/311
• Received 800 mg IBA every 2 weeks, with or without a loading dose
• HIV-1 infection
• 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)

Sponsors & Collaborators

• Epividian: lead
• Theratechnologies: collaborator
• FIECON: collaborator

Study Sites (1)

Epividian

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Interventions

ibalizumab

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: August 5, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)