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OpenTrials
Completed

NCT Number: NCT05495204

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

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.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Epividian

Durham, North Carolina, 27703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibalizumab

Drug

Participation in clinical trials vs. routine care in OPERA

Other names: Regimens not containing ibalizumab

Primary outcomes

  1. Viral suppression

    Time frame: Week 24

    Viral load <200 copies/mL

  2. Viral suppression

    Time frame: Week 48

    Viral load <200 copies/mL

  3. Viral suppression

    Time frame: Week 60

    Viral load <200 copies/mL

  4. Viral suppression

    Time frame: Week 96

    Viral load <200 copies/mL

  5. Viral undetectability

    Time frame: Week 24

    Viral load <50 copies/mL

  6. Viral undetectability

    Time frame: Week 48

    Viral load <50 copies/mL

  7. Viral undetectability

    Time frame: Week 60

    Viral load <50 copies/mL

  8. Viral undetectability

    Time frame: Week 96

    Viral load <50 copies/mL

Sponsors and collaborators

Lead sponsor

Epividian

Industry

Collaborators

  • FIECON
  • Theratechnologies

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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