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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: Active study of HIV Infections and Multi-Antiviral Resistance, sponsored by Theratechnologies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment vs. matched patients not receiving ibalizumab. And to evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretrovirals. The following data will be collected: RELEVANT DISEASE AND PATIENT CHARACTERISTICS: * HIV Type * Duration of HIV infection * Gender * Age * Race/ethnicity * Vital signs (weight (kilograms), height (meters), systolic and diastolic blood p
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 |
What the registry record for NCT05388474 still lists
NCT05388474 is an observational study that tracks outcomes without assigning an intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
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Where NCT05388474's enrollment target sits among peer trials
168 196th of 542 higher than 344 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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