A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
Public ClinicalTrials.gov record NCT05388474. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05388474
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Interventions
- No ibalizumab or Pre-ibalizumab treatment Other
- On ibalizumab treatment Biological
Other · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 21, 2022
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
- Last update posted
- Jul 26, 2026
2022 – 2026
United States locations
- U.S. sites
- 36
- U.S. states
- 14
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ruane Clinical Research | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90046 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| UC San Diego Owen Clinic | San Diego | California | 92103 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Circle Care Center | Stamford | Connecticut | 06850 | — |
| Waterbury Hospital | Waterbury | Connecticut | 06702 | — |
| Whitman Walker Health | Washington D.C. | District of Columbia | 20005 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Aids Healthcare Foundation | Fort Lauderdale | Florida | 33308 | — |
| Gary J. Richmond, M.D., PA | Fort Lauderdale | Florida | 33316 | — |
| Midway Specialty Care Center Miami Beach | Miami Beach | Florida | 33140 | — |
| Orlando Immunology Center (OIC) | Orlando | Florida | 32803 | — |
| Bliss Health | Orlando | Florida | 32806 | — |
| Can Community Health | Tampa | Florida | 33614 | — |
| St-Joseph's Comprehensive Research | Tampa | Florida | 33614 | — |
| CAN Community Health | Tampa | Florida | 34232 | — |
| Triple O Research Institute PA | West Palm Beach | Florida | 33407 | — |
| Indiana University Health Inc. | Bloomington | Indiana | 47405 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| The Research Institute | Springfield | Massachusetts | 01105 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Las Vegas Research Center | Las Vegas | Nevada | 89106 | — |
| I.D. Care Associates, PA | Hillsborough | New Jersey | 08844 | — |
| Prime Healthcare Services - St Michael's Medical Center | Newark | New Jersey | 07102 | — |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | — |
| Amity Medical Group | Charlotte | North Carolina | 28215 | — |
| The Roper St. Francis Ryan White Wellness Center | Charleston | South Carolina | 29407 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Prism Health North Texas | Dallas | Texas | 75204 | — |
| North Texas Infectious Diseases Consultants, P.A | Dallas | Texas | 75246 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| UT Health Houston | Houston | Texas | 77030 | — |
| St. Hope Foundation | Houston | Texas | 77036 | — |
| Legacy Community Pharmacy Services | Houston | Texas | 77074 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05388474, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05388474 live on ClinicalTrials.gov.