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NCT05388474 · ClinicalTrials.gov registry record
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
A clinical trial of HIV Infections and Multi-Antiviral Resistance, sponsored by Theratechnologies.
- Active
- Registry status
- 168
- Enrollment target
- 20
- Study locations
NCT05388474 is a study of HIV Infections and Multi-Antiviral Resistance that is active but no longer recruiting, run by Theratechnologies. The registered enrollment target is 168 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05388474, a study of HIV Infections and Multi-Antiviral Resistance, is active but no longer recruiting, sponsored by Theratechnologies.
- ACTIVE NOT RECRUITING
- Registry status
- 168 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- OTHER No ibalizumab or Pre-ibalizumab treatment
- BIOLOGICAL On ibalizumab treatment
Study Locations (20)
Florida
- Aids Healthcare Foundation - Fort Lauderdale
- Gary J. Richmond, M.D., PA - Fort Lauderdale
- Midway Specialty Care Center Miami Beach - Miami Beach
- Orlando Immunology Center (OIC) - Orlando
- Bliss Health - Orlando
- Can Community Health - Tampa
- St-Joseph's Comprehensive Research - Tampa
- CAN Community Health - Tampa
- Triple O Research Institute PA - West Palm Beach
California
- Ruane Clinical Research - Los Angeles
- Mills Clinical Research - Los Angeles
- BIOS Clinical Research - Palm Springs
- UC San Diego Owen Clinic - San Diego
Connecticut
- Yale University - New Haven
- Circle Care Center - Stamford
- Waterbury Hospital - Waterbury
District of Columbia
- Whitman Walker Health - Washington D.C.
- Georgetown University Medical Center - Washington D.C.
Indiana
- Indiana University Health Inc. - Bloomington
Maryland
- University of Maryland School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2026-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05388474
The ClinicalTrials.gov registry entry for NCT05388474 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower). The listed sponsor is Theratechnologies, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which No ibalizumab or Pre-ibalizumab treatment is the first listed.
NCT05388474 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05388474 about?
NCT05388474 is a clinical study titled "A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab". 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 patie...
What is the current status of trial NCT05388474?
This trial is currently active not recruiting. The enrollment target is 168 participants. The study started on 2022-03-22. Estimated completion is 2026-06.
What conditions does trial NCT05388474 study?
This clinical trial studies the following conditions: HIV Infections, Multi-Antiviral Resistance.
What interventions are being tested in trial NCT05388474?
The interventions under investigation include: No ibalizumab or Pre-ibalizumab treatment (OTHER), On ibalizumab treatment (BIOLOGICAL).
Who is sponsoring clinical trial NCT05388474?
This trial is sponsored by Theratechnologies, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05388474 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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