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A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab

NCT05388474 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2026-01-02

No results posted yet for this study

Summary

The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end.

Primary Objective:

To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab.

Secondary Objective:

To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment.

To assess the long-term safety and tolerability of ibalizumab.

Other Objectives:

To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll.

Conditions

  • HIV Infections
  • Multi-Antiviral Resistance

Interventions

OTHER

No ibalizumab or Pre-ibalizumab treatment

Patient registry

BIOLOGICAL

On ibalizumab treatment

Patient registry

Sponsors & Collaborators

  • Excelsus Statistics Inc.

    collaborator UNKNOWN

  • Health Psychology Research Group (HPR)

    collaborator UNKNOWN

  • ICON Clinical Research

    collaborator INDUSTRY

  • Theratechnologies

    lead INDUSTRY

Principal Investigators

  • Princy N Kumar, MD · Georgetown University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388474 on ClinicalTrials.gov